REPROCESSED LAPAROSCOPIC HAND INSTRUMENTS, NON-ELECTRIC

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THE DEVICE WAS REPROCESSED. THE LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THE REPORTED ISSUE WAS CONFIRMED. THE INSULATION WAS OFF OF THE DEVICE WHEN RECEIVED. THE USER FACILITY CONFIRMED THAT THE INSULATION WAS RETRIEVED FROM THE PATIENT AT THE TIME OF THE PROCEDURE; GENERAL ANESTHESIA WAS USED; HOWEVER THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE AT THIS TIME, HOWEVER IF MORE INFORMATION IS PROVIDED THEN THIS REPORT WILL BE UPDATED. IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.

Description of Event or Problem

WE RECEIVED A REPORT INDICATING WHILE USING A REPROCESSED RE-NEW LL ENDOCUT SCISSOR TIP, THE BLACK INSULATION LOCATED ON THE SHAFT OF THE DEVICE, FELL OFF DURING USE. THE INSULATION WAS LOCATED AND RETRIEVED FROM THE PATIENT BY THE SURGEON AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.