Cook Medical G50871 - STAPLE, LINE REINFORCEMENT, C-SLRA-ECH60, 5/BX

Cook Medical G50871 - STAPLE, LINE REINFORCEMENT, C-SLRA-ECH60, 5/BX

Biodesign Staple Line Reinforcement

Cook Medical offers a significant innovation to improve bariatric and thoracic surgical procedures with the U.S. launch of the self-adhesive Surgisis Biodesign Staple Line Reinforcement. Offering surgeons an ease of use that was previously unavailable, the self-adhesive graft is a natural solution for the reinforcement of gastric staple lines during gastric bypass procedures. The graft is designed to improve staple line strength while decreasing bleeding, leakage and the subsequent risk of infection.

Device Characteristics

Intended Use

The Biodesign Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Staple Line Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/ pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

Staple Line Reinforcement

• This product is intended for use by trained medical professionals.
• This device is supplied sterile and is intended for one-time use.

Contraindications

This Staple Line Reinforcement is derived from a porcine source and should not be used in patients with known sensitivity to porcine materials. This Staple Line Reinforcement contains fructose and should not be used in patients with known sensitivity to fructose.

Precautions

• This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.
• Do not resterilize. Discard open and unused portions.
• Staple Line Reinforcement is sterile if the package is dry, unopened, and undamaged. Do not use if package seal is broken.
• Discard Staple Line Reinforcement if mishandling has caused possible damage or contamination or if Staple Line Reinforcement is past its expiration date.
  NOTE: Staple Line Reinforcement may get damaged if foam applicator is folded.
• Follow the manufacturers instructions regarding the use of the stapler, including precautions regarding use with staple reinforcement materials.
  NOTE: When firing across thick tissue, holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression and staple formation.
• Use stapler loads that allow for combined thickness of tissue and the Staple Line Reinforcement.*
• Use only specified staplers with appropriate sized Staple Line Reinforcement.
• This device is designed for use with flat surface reloads.
• Use of uneven surface reloads could lead to insufficient device adherence.
• If an uneven surface reload is used, adherence may be improved by use of the warming tray method of device preparation (see instruction for use option A).
• Ensure that prior to firing the surgical stapler the entire active portions of stapler jaws are covered by the reinforcement device.
• Fire the stapler within 10 minutes after applying the Staple Line Reinforcement. Otherwise, the device may be difficult to dislodge from the stapler jaws after firing.
• Avoid dropping the tray-device assembly from the pouch onto the sterile field.
• Avoid using the tail to remove the Staple Line Reinforcement from the tray as it could lead to premature detachment from the foam applicator.
• Avoid trying to re-adhere the Staple Line Reinforcement to the stapler if it comes off.
• Avoid excessive manipulation of tissue with a stapler loaded with the Staple Line Reinforcement.
• To prevent loss of adhesive, avoid dipping the Staple Line Reinforcement in water/saline. Dip the stapler jaws instead.

Potential Complications

• Infection
• Acute or chronic inflammation (Initial application of graft materials may be associated with transient, mild, localized inflammation)
• Allergic Reaction

Instructions for Use

Required Materials

• Compatible surgical stapler
• Warm sterile water or saline (up to 120?/49?)
• Sterile scissors
• Sterile basin
• Sterile gauze or sponge
• Solution warmer (minimum of 104? up to 120? temperature capacity for best results)
• Perforated instrument tray
• Sterile towels

NOTE: Always handle the Staple Line Reinforcement using aseptic technique, minimizing contact with latex gloves.

A. Device Preparation Using Warming Tray Method

NOTE: This method is suitable for device preparation when either an uneven surface or flat surface reload is used.

1. Set solution warmer temperature to 120? for best results (minimum temperature 104?)
2. Follow the instructions for use supplied by the solution warmer manufacturer.
3. Pour sterile water or saline into the basin to approximately 1 (25mm) high.
4. Put a sterile instrument tray in the basin.
   Ensure that the instrument tray is suspended above the waterline. Caution: Do not submerge the device.
5. Aseptically remove the tray-device assemblies from their pouches using sterile gloved hands and line up in the instrument tray.
6. Cover the instrument tray with lid (if available).
7. Drape sterile towels over the entire instrument tray and solution warmer basin.
8. Wait 10 minutes before loading a Staple Line Reinforcement onto the stapler.
9. Once the Staple Line Reinforcement adhesive is activated proceed to Section C for instructions to load the stapler.

Note: If an additional Staple Line Reinforcement is needed for the procedure, place tray-device assembly in the warming tray, cover with sterile towels and wait an additional minute before loading the Staple Line Reinforcement. For best results, place the stapler jaws in the warming tray prior to loading the Staple Line Reinforcement.

B. Device Preparation Using Stapler Warming Method

NOTE: This method is only suitable for device preparation when a flat surface reload is used.

• Aseptically remove the tray from inside the pouch using sterile gloved hands and place into the sterile field.
• Pour warm water or saline into a deep warming basin or insulated canister such that the entire stapler jaws can be completely submerged.
• Dip and hold the jaws of the surgical stapler or re-load into the sterile water or saline for 3 seconds to warm the stapler jaws.
• Remove from the basin. Position the stapler jaws vertically and tap the stapler reload to allow excess water to drip off. Proceed to Section C for instructions to load the stapler.

C. Loading Stapler Instructions

• Pull the Staple Line Reinforcement out of the tray by the finger grips on wings of the foam applicator. Do not pull out of the tray by the tail.
• Place the applicator inside the jaws of the surgical stapler. Align the parallel edges of the applicator with the cartridge side edge of the stapler jaws. Gently insert the applicator to the back of the stapler jaws until the applicator cannot go any further. Notches in the applicator provide for a stopping point to indicate how far back the applicator should be positioned in the stapler jaws.
  
  
• Close the stapler on the applicator. Grip the tail of the foam applicator and detach it. Discard the tail of the applicator.
  
  
• Keep the stapler tightly closed for at least 5 seconds after the applicator tail is removed. For reload cartridges with a contoured surface, compress for 10 seconds.
  (For Covidien staplers, use fingers to provide uniform compression to the applicator.)
  
  
• Open the stapler jaws, remove and discard the remaining portion of the foam applicator. Inspect device alignment to ensure complete coverage of both cartridge and anvil stapler jaws. Inspect the adhered Staple Line Reinforcement to ensure that none of the foam applicator parts are stuck. If required, using sterile scissors, cut off any excess length of the Staple Line Reinforcement strip that protrudes from the tip of the stapler jaws, being certain not to dislodge the strip from the stapler jaws.
  
  
• Move the stapler or re-load to the operative site and continue with the procedure. Use caution to avoid displacing the Staple Line Reinforcement from the stapler jaws. Use the stapler within 10 minutes after applying the Staple Line Reinforcement to the stapler.
  NOTE: Before applying a new staple line reinforcement to Ethicon Endostaplers, between fires, wash off the anvil side in clean water and then wipe the anvil side of the stapler jaws with a dry piece of gauze or sterile cloth.
• Discard any unused portions of the Staple Line Reinforcement following standard technique for disposal of medical waste.