Medtronic HEM3348 Instructions for Use

K L

EEA™

Hemorrhoid and Prolapse Stapler with DST Series™ Technology

PT00167809

K L

8. Do not use the instrument unless there is sufficient tissue to allow proper inversion of tissue edges so staples can be

J B E

O P Q R S T U

.30mm x

33mm 1.5mm

33mm

24.6mm 32

24.6mm

2.0mm

.20mm

.30mm x

.20mm

BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.

IMPORTANT!

This booklet is designed to assist in using this product. It is not a reference to surgical techniques.

This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life- threatening injury. Do not reuse, reprocess or resterilize this device.

DESCRIPTION

The EEA™ hemorrhoid and prolapse stapler set with DST Series™ technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium staples and removes a circular tissue specimen. The instrument is offered in a 33 mm diameter size with either 3.5 mm or 4.8 mm staples.

The accompanying accessories are comprised of an access port, anoscope, and dilator.

The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure.

The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum.

The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue.

Both the anoscope and port are transparent to facilitate visualization of the anal canal.

The product is to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The EEA™ Hemorrhoid and Prolapse Stapler with DST Series™ Technology is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

INDICATIONS

The EEA™ hemorrhoid and prolapse stapler set with DST Series™ technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA™ hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.

CONTRAINDICATIONS

1. This device is not designed, sold, or intended for use except as indicated.

2. The instrument should not be used on tissues which, in the opinion of the surgeon, would not be able to tolerate conventional suture materials or conventional closure techniques. Such tissue may include but is not limited to: gangrenous, abscessed, infected, necrotic or ischemic tissue.

3. Do not use the instrument with 4.8 mm staples on any tissue that compresses to less than 2.0 mm in thickness. In such cases, the staples will not be tight enough to ensure hemostasis.

4. Do not use the instrument with 4.8 mm staples on any tissue that will not comfortably compress to 2.0 mm in thickness. The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window. If these instructions are not followed, closure failure, tissue trauma, dehiscence, tissue tearing, and displacement may occur, and/or hemostasis may not be obtained.

5. Do not use the instrument with 3.5 mm staples on any tissue that compresses to less than 1.5 mm in thickness. In such cases, the staples will not be tight enough to ensure hemostasis.

6. Do not use the instrument with 3.5 mm staples on any tissue that will not comfortably compress to 1.5 mm in thickness. The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window. If these instructions are not followed, closure failure, tissue trauma, dehiscence, tissue tearing, and displacement may occur, and/or hemostasis may not be obtained.

7. The instrument should not be used if the diameter of the rectum cannot accommodate the stapler and accessories (port, anoscope, dilator).

placed securely in the inverted edges. The pursestring suture must be tied snugly through one of the holes on the center rod of the anvil/center rod assembly.

9. Do not use the stapler where adequacy of hemostasis cannot be verified visually after firing.

WARNINGS AND PRECAUTIONS

1. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving stapling devices prior to employing this device.

2. Make sure tissue is within indicated thickness range. As with all surgical staplers, surgeons should consider specific patient factors before deciding if the device is suitable for use. For example, preoperative radiotherapy may result in changes to tissue. These changes may, for example, cause the tissue thickness to exceed the indicated range for the staple. Careful consideration should be given to any pre-surgical treatment the patient may have undergone to ensure appropriateness of device application.

3. Make certain that the section of tissue to be stapled is free from any unintended obstructions such as metal clips or other similar structures; otherwise, the knife blade may not cut and staples may not form properly when firing, which may result in poor hemostasis and/or leakage. Use of the anvil/center rod assembly anchor point most distal from the anvil (marked with an orange caution band) should be reserved for instances involving the greatest amount of prolapse only and should be used by experienced users only.

4. Visually inspect prior to firing for inclusion of unintended anatomic structures within the staple line or within the pursestring.

5. There is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when a surgeon may deem it necessary or appropriate to do so.

6. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.

7. Avoid use of the device on the aorta.

8. Make certain the space between the cartridge and anvil is closed snugly and the tissue is compressed. Inspect and ensure that the green bar is visible in indicator window prior to firing the stapler. The stapler will not fire if the indicator does not show green.

CAUTION: Any unusual effort required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window may indicate excessive tissue, uneven tissue capture, or the need to use a larger staple size (use of a larger staple size is applicable to 3.5 mm staples only).

9. To ensure that the green ready-to-fire indicator remains visible, do not turn the twist knob once the safety is released.

10. When firing the device, squeeze the handle as fully as possible. Only fire the instrument one time. Replace safety latch when fire is completed.

11. DO NOT TURN THE TWIST KNOB MORE THAN ONE (1) TURN COUNTERCLOCKWISE after firing. Doing so may result in difficulty in removing the device or separation of the anvil assembly.

12. After removal of the instrument, always inspect the staple line and the surrounding site for hemostasis and/or leakage. Minor bleeding may be controlled by electrocautery or manual sutures. Minor leakage may be controlled by manual sutures.

13. Following removal of tissue specimens from the shaft, dispose of the instrument. To prevent injury, do not touch the circular knife blade.

14. The tissue specimens (“donuts”) should be inspected to ensure that all desired tissue layers have been incorporated. If the specimens are not complete, a leak could result and cause narrowing.

15. Avoid handling the top rim of the cartridge to prevent possible injury from the circular knife.

16. Use of an improperly matched instrument and anvil combination will cause staple malformation or result in the failure of the instrument to cut properly. Malformed staples may compromise the integrity of the staple line resulting in leakage or disruption. Use only with anvil supplied with the instrument.

17. Pursestring sutures for hemorrhoidopexy should be placed in mucosa and submucosa tissues only and should not extend into the muscularis tissues.

18. End-to-end and end-to-side anastomoses require a FULL thickness pursestring suture to properly gather sufficient tissues into the EEA™ cartridge and anvil assembly and create an effective anastomosis.

19. The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.

20. Excess tissue thickness or significantly uneven tissue thickness may result in unacceptable staple formation and/or incomplete knife cut.

21. Failure to squeeze the handle fully during firing may result in unacceptable staple formation and/or an incomplete knife cut. This may result in leakage. Ensure that the handle is fully squeezed when the metal underside of the handle contacts the stapler body to the fullest extent.

22. Do not try moving the stapler at the same time as opening it. Doing so may result in the anvil catching on the anastomotic lip.

23. Contact of the instrument with mercuric chloride solutions may cause a chemical reaction and should be avoided.

24. This device and included accessories are provided STERILE and are intended for a single firing in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

25. Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements.

26. For female patients, always ensure that rectovaginal tissues have not been incorporated into the pursestring or within the instrument prior to firing the device.

27. Compatibility of other manufacturer’s staple line reinforcement material for use with the EEA™ hemorrhoid and prolapse stapler with DST Series™ technology has not been determined.

ADVERSE REACTIONS

Adverse reaction and potential complications associated with the use of the hemorrhoid and prolapse stapler with DST Series™ technology include: anastomotic leak, infection, bleeding, thrombosis, tissue damage, stenosis, pain, incontinence, rectovaginal fistula when device is used improperly

SCHEMATIC VIEW

A) CARTRIDGE SHIPPING CAP

B) CENTER SHAFT (FULLY EXTENDED)

C) STAPLE CARTRIDGE

D) SHELL WITH DEPTH MARKINGS

E) STAPLER

F) READY - TO - FIRE INDICATOR

G) TWIST KNOB

H) SAFETY

I) HANDLE

J) ANVIL / CENTER ROD ASSEMBLY

K) PORT

L) ANOSCOPE

M) DILATOR

INSTRUCTIONS FOR USE

CAUTION: Pursestring sutures for hemorrhoidopexy should be placed in mucosa and submucosa tissues only and should not extend into the muscularis tissues.

Using Anoscope to place pursestring for hemorrhoidopexy:

1. Lubricate the dilator (M) and insert into the anal canal, immediately remove.

2. Nest the accessories together (dilator (M) inside of the anoscope (L) inside of the port (K) and then insert the nested accessories into the anal canal).

3. Remove the dilator and anoscope and secure the port (K) to the buttocks with stay sutures.

4. Thread the loose end of the pursestring suture through the open end of the anoscope, under the transparent bridge, and back over the outside of the bridge towards the opening. Attach a clamp to the loose end of suture and place behind one of the anoscope handles and out of the way.

5. Reinsert the anoscope (L) and dilator (M) and then remove the dilator. The dilated anal canal and transparent anoscope enables the dentate line and underlying anatomy to be visualized.

6. Use the anoscope markings for a consistent placement of the pursestring suture in the mucosa and submucosa, proximal to the dentate line with enough distance to ensure the final staple line will be appropriately proximal to the dentate line.

NOTE: The appropriate location of the pursestring may vary within the suggested range depending on degree of prolapsed mucosa and the desired amount of tissue to be removed.

7. After the pursestring is completed (mucosa and submucosa only), remove the anoscope.

NOTE: The access port remains in place throughout entire procedure.

8. Upon removal of the stapler and anvil/center rod assembly from the package, remove and discard cartridge shipping cap.

NOTE: The anvil and center rod assembly are one piece and are non-detachable.

Detached Anvil Technique:

1. After the pursestring suture has been placed (mucosa and submucosa only) and checked, assess how much tissue is to be removed and pass the anvil head beyond the pursestring suture. Select an appropriate anchor point on the anvil/ center rod assembly.

2. Cinch the pursestring around the anvil/center rod assembly (J) and thread one lead of the pursestring suture into the desired hole in the anvil/center rod assembly. Pass the remaining lead through the same hole but in the opposite direction and secure the pursestring to the anvil/center rod assembly with appropriate tension and knotting. Add gentle traction to the anvil/center rod assembly while checking to confirm that all desired tissue has been gathered and that no unwanted tissue has been incorporated.

3. Fully extend the center shaft of the stapler (E) by turning the twist knob (G) counter clockwise until it stops. Mate the anvil/center rod assembly (J) to the stapler by inserting the blunt anvil/center rod assembly into the center shaft (B) of the stapler and push firmly until the anvil/center rod assembly clicks into its fully seated position. This click will be tactile and audible. Manually inspect the attachment to ensure that the anvil/center rod assembly and stapler are fully mated.

4. While holding the device perpendicular to the anus, fully clamp device by turning the twist knob (G) clockwise until the ready-to-fire indicator (F) displays a green bar (N). Allow the instrument and anvil to close naturally with neutral tension.

For female patients, digitally inspect the tissues captured within the instrument to ensure that rectovaginal tissues have not been incorporated.

NOTE: The safety latch will not release if the green bar is not visible in the ready-to-fire indicator.

5. To fire the instrument, release the safety latch (H) above the handle (I) and squeeze the handle firmly as far as it will go. An audible and tactile click will indicate full firing of the stapler.

CAUTION: To ensure that the green bar remains visible in the ready-to-fire indicator window, do not turn the twist knob once the safety is released.

6. After firing, release the handle, and return the safety to the locked position.

7. To remove the instrument, create a space between the cartridge and anvil by turning the twist knob counterclockwise ONE (1) turn.

CAUTION: DO NOT TURN THE TWIST KNOB MORE THAN ONE (1) FULL TURN COUNTERCLOCKWISE after firing. Doing so may result in difficulty in removing the device or separation of the anvil assembly.

CAUTION: When opening the stapler prior to removal, DO NOT TURN THE TWIST KNOB MORE THAN ONE AND A HALF (1½) FULL TURNS COUNTERCLOCKWISE, as this may allow the anvil assembly to separate from the instrument.

8. Gently remove the instrument. Following removal, inspect the staple line for hemostasis.

9. Turn the twist knob counterclockwise to open the instrument and inspect the tissue specimens (“donuts”) to ensure that all desired tissue layers have been incorporated in the anastomosis.

CAUTION: Avoid handling the top rim of the cartridge to prevent possible injury from the circular knife.

Attached Anvil Technique:

2. Thread one lead of the pursestring suture into the desired hole in the anvil/center rod assembly and then pass the remaining lead through the same hole but in the opposite direction and secure the pursestring to the anvil/center rod assembly with appropriate tension and knotting.

3. Check to confirm that all desired tissue has been gathered and that no unwanted tissue has been incorporated.

4. Follow steps 4-9 as instructed above in Detached Anvil Technique.

CAUTION: End-to-End and End-to-Side anastomoses require a FULL thickness pursestring suture to properly gather sufficient tissues into the EEA™ cartridge and anvil assembly and create an effective anastomosis.

End-to-end and end-to-side techniques (Without use of Anoscope):

1. Place an appropriate FULL thickness pursestring in the tissues to be anastomosed using standard double pursestring technique.

2. Fully extend the center shaft of the stapler by turning the twist knob counter clockwise until it stops. Mate the anvil/center rod assembly to the stapler by inserting the blunt anvil/center rod assembly into the center shaft of the stapler and push firmly until the anvil/center rod assembly clicks into its fully seated position. This click will be tactile and audible. Manually inspect the attachment to ensure that the anvil/center rod assembly and stapler are fully mated. Turn twist knob 3 ½ full turns clockwise to retract anvil.

3. After FULL thickness pursestring has been placed and checked, insert stapler into position.

4. Open the stapler by turning the twist knob counterclockwise until sufficient space is available between the cartridge and the anvil for the structures to be anastomosed.

5. Tie the distal pursestring suture (securely but not too tight) above the plastic alignment guide on the anvil/center rod assembly to secure tissue over the cartridge. Ensure the pursestring suture is securely tied with sufficient space to enable the pursestring to smoothly slip over the anvil/center rod assembly when closing the stapler. Tie the proximal pursestring suture securely onto the anvil/center rod assembly to secure proximal tissue around the anvil.

6. To approximate the tissue and to close the space between the cartridge and anvil, turn the twist knob clockwise until it stops. Use care to avoid trapping unintended tissues between the anvil and cartridge. Proper approximation is verified when a green bar is visible in the ready-to-fire indicator window signifying that the stapler is ready to be fired.

NOTE: The safety will not release if the green bar is not visible in the indicator window.

CAUTION: The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.

CAUTION: Excess tissue thickness or significantly uneven tissue thickness may result in unacceptable staple formation and/or incomplete knife cut.

7. To fire the instrument, release the safety latch underneath the instrument handle and fully squeeze the instrument handle until the underside of the handle contacts the stapler body to the fullest extent. Audible and tactile firing indications will provide additional feedback of firing completion; however, even at the presence of these indications, it is important to fully squeeze the handle to ensure complete firing.

CAUTION: Failure to squeeze the handle fully during firing may result in unacceptable staple formation and/ or an incomplete knife cut. This may result in leakage. Ensure that the handle is fully squeezed when the metal underside of the handle contacts the stapler body to the fullest extent.

8. Following release of the handle, return the safety to the locked position.

9. To remove the instrument, create a space between the cartridge and anvil by turning the twist knob counterclockwise ONE (1) turn.

CAUTION: DO NOT TURN THE TWIST KNOB MORE THAN ONE (1) FULL TURN COUNTERCLOCKWISE after firing. Doing so may result in difficulty in removing the device or separation of the anvil assembly.

CAUTION: DO NOT try moving the stapler at the same time as opening it. Doing so may result in the anvil catching on the anastomotic lip.

10. Gently remove the instrument by pulling it straight out of the new anastomosis. Following removal, inspect the staple line for hemostasis and check the anastomosis for integrity.

11. Inspect the tissue specimens (“donuts”) to ensure that all tissue layers have been incorporated in the anastomosis. Turning the twist knob in a counterclockwise direction will cause the anvil/center rod assembly to extend, permitting inspection of the tissue specimens.

CAUTION: End-to-end and end-to-side anastomoses require a FULL thickness pursestring suture to properly gather sufficient tissues into the EEA™ cartridge and anvil assembly and create an effective anastomosis.

End-to-end and end-to-side techniques (With use of anoscope):

1. Lubricate the dilator and insert into the anal canal, immediately remove.

2. Nest the accessories together (dilator inside of the anoscope inside of the port and then insert the nested accessories into the anal canal).

3. Remove the dilator and anoscope and secure the port to the buttocks with stay sutures.

5. Reinsert the anoscope. The dilated anal canal and transparent anoscope enables the dentate line and underlying anatomy to be visualized.

6. Using the anoscope markings to maintain a consistent pursestring placement, place a FULL thickness pursestring suture in the subject tissues.

NOTE: The appropriate location of the pursestring may vary within the suggested range depending on the desired amount of tissue to be removed.

7. Place an appropriate full thickness pursestring in the other tissues to be anastomosed.

8. After the pursestring is completed, remove the anoscope.

9. Proceed to Step 3 of the above section end-to-end and end-to-side techniques (Without use of Anoscope): and continue with anastomosis.

NOTE: The access port remains in place throughout entire procedure.

STAPLE SPECIFICATION CHART

O) SIZE OF STAPLE (4 mm BACKSPAN, 3.5 AND 4.8 mm LEG LENGTHS)

P) APPROXIMATE CLOSED STAPLE HEIGHT (HEIGHT OF “B”)

Q) STAPLE CROSS SECTION DIMENSIONS (WIRE SIZE)

R) SHELL OUTSIDE DIAMETER

S) OUTSIDE KNIFE DIAMETER

T) NUMBER OF STAPLES

U) TISSUE COMPRESSION REQUIREMENT

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Medtronic HEM3348 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual