XS APPL.FCPS.STD.TI.90/230MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. D4 - BATCH AND SERIAL NUMBER. D9 - PRODUCT RETURN. H3 - EVALUATION. H4 - MANUFACTURE DATE. INVESTIGATION RESULTS: INVESTIGATION HAS BEEN CARRIED OUT IN COOPERATION WITH THE PRODUCTION PLANT. THE FORCEPS HAS BEEN TESTED AGAINST THE TEST PLAN VALID AT THE TIME OF PRODUCTION. ALL DIMENSIONS ARE TRUE TO GAUGE, FUNCTIONAL TESTS, ESPECIALLY THE RELEASE FUNCTION, WERE CARRIED OUT SUCCESSFULLY. RESIDUES CAN BE FOUND ALL OVER THE SURFACE OF THE INSTRUMENT. DEVICE HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE ABOVE-MENTIONED INVESTIGATION RESULTS A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE FORCEPS IS ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO FAILURE DETECTED AND THEREFORE THE SUB-ITEMS OF "CONCLUSION OF STATISTICAL ANALYSIS" CANNOT BE APPLIED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

Description of Event or Problem

UPDATE: THERE WAS A 5 MINUTE DELAY IN SURGERY. AN ADDITIONAL INSTRUMENT SET WAS OPENED AND A BACKUP NON-LOCKING APPLIER USED INSTEAD.

Description of Event or Problem

IT WAS REPORTED TO AESCULAP AG THAT A XS APPL.FCPS.STD.TI.90/230MM (MATERIAL # FT495T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, DURING AN EMERGENCY CLIPPING OF RUPTURED ANEURYSM SURGERY, THE LOCKING ANEURYSM CLIP APPLIERS WOULD NOT RELEASE TO CLOSE THE TEMPORARY CLIPS. THE PATIENT LOST A TREMENDOUS AMOUNT OF BLOOD BECAUSE THE TEMPORARY CLIPS WOULD NEITHER CLOSE OR RELEASE. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS WAS A LIFE THREATENING SITUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.