LONE STAR RETRACTOR HOOKS

Additional Manufacturer Narrative

(B)(4). AN INVESTIGATION WAS LAUNCHED TO IDENTIFY POTENTIAL ROOT CAUSES. THE INVESTIGATION WAS CARRIED OUT INTERNALLY BY COOPERSURGICAL QUALITY ENGINEERS. THE CUSTOMER DID NOT RETURN THE ACTUAL COMPLAINT SAMPLE. DHR REVIEW OF WO#145176 ((B)(4) UNITS) SHOWS PN 3205-8G WAS MANUFACTURED, ASSEMBLED, INSPECTED, AND TESTED PER ESTABLISHED PROCEDURES IN AUGUST 2013. THERE WERE NO ISSUES IDENTIFIED WITH THE DEVICE(S) PER DHR REVIEW. TWO BOXES OF PN3205-8G FROM LOT #145176 WERE RETRIEVED FROM INVENTORY AND TESTED WITH INSTRON. THE TEST CONFIRMED (6 OUT OF 16) THAT MINIMUM 8.8 LBF FORCE WAS NEEDED TO EITHER BREAK THE STAY TAIL OR PULL THE HOOK WITH HEAT SHRINK OFF THE TAIL. A REVIEW OF THE TWO YEAR COMPLAINT HISTORY REVEALED NO COMPLAINTS FOR THIS PN. FURTHER REVIEW OF COMPLAINT HISTORY SHOWS SINCE 1999 THERE HAVE BEEN TOTAL FIVE COMPLAINTS. IN ALL CASES INVESTIGATIONS CONFIRMED THAT EXCESSIVE FORCE MAY HAVE CAUSED THE SEPARATION OF THE HOOK FROM TAIL AND A FORCE OF 18.5 LBF IS NEEDED TO BREAK HOOK FROM THE HEAT SHRINK. PRO-STAY 8PK STAYS ARE INTENDED FOR GENTLE RETRACTION AND ARE LABELED WITH PN 828-3290 THAT STATES: "NOTICE: DO NOT USE FORCEPS. USE GENTLE RETRACTION." NO ASSESSMENT COULD BE DONE ON THE ACTUAL PRODUCT DUE TO NO SAMPLE RETURNED OR PICTURES PROVIDED TO COOPERSURGICAL. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME. COOPERSURGICAL WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR ANY TRENDS.

Description of Event or Problem

MEDWATCH UF/IMPORTER REPORT # (B)(4). "THE TIP OF PLASTIC STAY BROKEN OFF DURING SURGERY. THE STAY IS APPROXIMATELY 1MM IN DIAMETER (REF # (B)(4)). TWO TIPS WERE ACTUALLY BROKEN AND ONE WAS RETRIEVED BUT THE SECOND WAS NOT LOCATED AFTER A THOROUGH SWEEP OF THE VAGINA."