FOREIGN BODY FORCEPS, 28 CM

Additional Manufacturer Narrative

UPDATED SECTION D9 TO YES, AND ENTERED THE DEVICE RETURNED DATE TO THE MANUFACTURER. THE DEVICE WAS RETURNED TO OUR US FACILITY ON MARCH 23, 2025. IT WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

UPDATED SECTION G3 ADDING AWARE DATE 04/23/2025. CORRECTION TO H11 VERBAGE: THE DEVICE WAS RETURNED TO OUR US FACILITY ON APRIL 23, 2025. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

PER INVESTIGATION BY THE MANUFACTURING SITE: IT CAN BE ASSUMED THAT THE PLIERS BROKE DUE TO MECHANICAL OVERLOAD. DUE TO THE DIMENSIONS OF THE ITEM (DIAMETER OF 1 MM), THE PLIERS MUST BE USED WITH APPROPRIATE CARE. EXCESSIVE FORCE CAN THEREFORE LEAD TO SUCH DAMAGE. THE ABOVE CONDUCTED INVESTIGATIONS DID NOT REVEAL 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 SIMILAR COMPLAINTS, NO TREND WAS IDENTIFIED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE BREAKS EVERY TIME SURGEON TRIES TO USE IT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.