XS APPL.FCPS.STD.TI.90/230MM
Received Aug 9, 2023 · Event occurred Jul 14, 2023
Report 2916714-2023-00082 · MDR key 17493935
Device
Generic name
Cranial Implants
Manufacturer
Aesculap AgModel number
FT495TCatalog number
FT495T
Lot number
52315294
Product problems
- Failure to Fire
- Failure to Fire
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
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
INVESTIGATION COMPLETE.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO AESCULAP INC. 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. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4); (B)(4).