Detailed important risk information


PERI-STRIPS DRY with VERITAS Collagen Matrix (PSDV) Reinforcement Matrix – Indications and Important Risk Information

INDICATIONS FOR USE
PSDV Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

(Circular reinforcement only) PSDV reinforcement can be used for reinforcement of staple lines during gastric, bariatric, and small bowel procedures.

(Linear reinforcement only) PSDV Reinforcement can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures, and during gastric, small bowel, mesentery, colon, and colorectal procedures.

IMPORTANT RISK INFORMATION
The use of PSDV Reinforcement is contraindicated in patients with known sensitivity to bovine or acrylic material.

Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact functionality of the device.

Discard all open unused components. Do not use product if there is damage to the pouch or seals.

Ensure the staple line is completely covered with the buttress or inadequate coverage after firing may result.

Do not use PSDV Reinforcement if the product has been exposed (1) to solutions above room temperature, (2) to chemicals, antibiotics, or other substances other than specifically addressed in the instructions, (3) or if heat indicator has been activated.

Use care when removing loading unit components from the stapler to prevent buttress dislodgement.

Do not get the buttress wet before applying Gel, or the buttress may not adhere to the stapler properly.

Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly. The cartridge and anvil sides of the PSDV Reinforcement loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips.

Final tissue compression, including PSDV Reinforcement, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are overlapped. PSDV Reinforcement increases the total thickness of the area stapled by 0.4 mm – 1.2 mm (0.016” – 0.048”).

(Circular reinforcement only) Cartridge cones may be used for entry into the surgical site on the cartridge side of the stapler during endoscopic surgery. Before completion of surgery be sure to remove the cartridge cone from the surgical site.

Rx Only. For safe and proper use of this device, refer to the Instructions for Use.

USMP/390/15-0014 08/2015