Laparoscope, General & Plastic Surgery, Reprocessed

Reprocessed Xcel Bladeless Trocar (H12LP)

An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

Stryker

Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73.

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Optical Access System; 5mm x 100mm and 12mm x 100mm;

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Cannula and Seal; 5mm x 100mm and 12mm x 100mm

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.

The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.

- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.

Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm

The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.