It was reported during a laparoscopic toupet fundoplication about 2 1/2 hours into the procedure the doctor noticed a break in the seal of the trocar sleeve. The sleeve had been used with 5mm graspers, 5mm scissors, and the lcs. When replacing the sleeve as the cam was released on the stability thread, the locking mechanism broke. The sleeve and stability thread were replaced. The items were from an ftc 16 lap chole kit, lot #k46j41. There was no consequence to the patient.

Facility experienced an event with your endopath disposable trocar while performing a lap nissen fundoplication. The product complaint analysis team has completed its investigation of the device which was returned to co with product inquiry # 973426-1. The results of the investigation conducted by the appropriate engineers and technicians are listed below. Visual inspections & results: bullet tip condition n/a, desufflation lever condition conforming, inner gasket condition conforming, latch conditionn n/a, obturator condition n/a, outer gasket condition torn, reset button condition n/a, sleeve condition conforming, stopcock condition conforming, trocar condition n/a. Functional tests & results: does safety shield retract n/a, flapper door functional conforming, lockout functional n/a. Analysis conclusion: based upon the visual examination, the outer gasket was confirmed to be torn. There were no pieces created by the torn gasket. No conclusion could be reached as to how the gasket became torn. Co reviews each incident as it occurs in an effort to continuously improve the products and process.