STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON APRIL 9,2025. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE BASE OF THE JAWS BROKE AT THE PREPARATION FOR THE FIRST USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

CORRECTION IN SECTION D9 PRODUCT WAS RETURNED TO THE MANUFACTURER ON APRIL 2,2025. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

DEVICE EVALUATION: THE COMPONENT IS BROKEN IN THE SAME PLACES ON BOTH SIDES. SO, THE MOST PROBABLE ROOT CAUSE IS THAT THE JAW OF THE PLIERS BROKE DUE TO FORCE BEING APPLIED ON BOTH SIDES. A MANUFACTURING DEFECT CAN BE RULED OUT, AS IT CAN BE ASSUMED THAT THE JAW WOULD OTHERWISE HAVE BROKEN ON ONE SIDE OR AT THE RIVETS. THE ABOVE CONDUCTED INVESTIGATIONS DID NOT REAVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE OR ITS HISTORY. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS; NO TREND WAS IDENTIFIED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).