FORCEPS, 4 FR., 60 CM

Description of Event or Problem

IT WAS REPORTED THAT THE JAW OF THE GRASPING FORCEPS IS BROKEN FROM FIRST USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON FEBRUARY 4,2025. 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).

Additional Manufacturer Narrative

DEVICE EVALUATION: THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT IS MECHANICAL OVERLOAD BY THE USER. CONNECTING RIVET IN THE JOINT BROKEN/SHEARED OFF DUE TO MECHANICAL OVERLOAD. CORROSION IN THE JOINT CAN ALSO HAVE A NEGATIVE EFFECT ON THE MATERIAL PROPERTIES. 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).