YASARGIL TI PERM STD-CLIP CVD 5.4MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT FT744T - YASARGIL TI PERM STD-CLIP CVD 5.4MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE ANEURYSM CLIP APPLIER FORCEPS INCLUDED IN THE AESCULAP ANEURYSM CLIP SET WERE EXHIBITING FUNCTIONAL MALFUNCTIONS DURING SURGICAL PROCEDURE. THE APPLIERS FAILED TO RELEASE THE ANEURYSM CLIPS AS INTENDED OR RETAIN THEM IMPROPERLY. THE FAILURE DID COMPROMISE TEMPORARY VESSEL OCCLUSION LEADING TO INTRAOPERATIVE HEMORRHAGE. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO.(B)(4). ASSOCIATED MEDWATCH REPORTS: FT742T (AESCULAP AG REFERENCE NO.(B)(4); 9610612-2025-00260), FT487T (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00258), FT744T (AESCULAP AG REFERENCE NO.(B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED D10- INVOLVED COMPONENTS H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, REVIEW OF VIDEO, AND EVENT DESCRIPTION. BASED ON THE PROVIDED VIDEOS, IT CAN BE OBSERVED THAT THE CIRCULATION LOCK IS NOT FUNCTIONING PROPERLY, WHICH INDICATES A DEFORMATION OF THE LOCKING COMPONENTS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCTS WERE FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO OTHER SIMILAR COMPLAINTS WITHIN THIS BATCH. FOR THE APPLIERS, NO BATCH NUMBER WAS PROVIDED. EVEN AFTER MEANINGFUL ATTEMPTS, FURTHER INFORMATION WAS NOT RECEIVED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS RELATED TO A USER ERROR. THE ERROR PATTERN COULD BE CONFIRMED. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. TO AVOID DAMAGES TO THE PRODUCT, THE INSTRUCTIONS FOR USE (IFU) VALID AT THE TIME OF USE MUST BE FOLLOWED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: THE FACILITY CONFIRMED THAT THE APPLICATORS HAD BEEN USED WITH TEMPORARY CLIPS FROM A NON-AESCULAP COMPANY. DUE TO THE FACT, THAT THE APPLICATORS WERE USED WITH OTHER COMPANY'S PRODUCTS, IT MAY BE POSSIBLE THAT THE APPLICATORS MAY HAVE BEEN "DEFORMED"; RESPECTIVELY THEIR FUNCTION MAY HAVE BEEN IMPAIRED AND THEREFORE DID NOT WORK PROPERLY WITH THE CLIPS.A VIDEO WAS RECEIVED WHICH SHOWED A DEFORMATION OF THE LOCKING COMPONENTS. ASSOCIATED MEDWATCH REPORTS: FT487T (AESCULAP AG REFERENCE NO.(B)(4); 9610612-2025-00258). INVOLVED COMPONENTS: FT742T /YASARGIL TI PERM STD-CLIPSLT-CVD 6.5MM (AESCULAP AG REFERENCE NO.(B)(4); 9610612-2025-00260). FT744T/ YASARGIL TI PERM STD-CLIP CVD 5.4MM (AESCULAP AG REFERENCE NO.(B)(4); 9610612-2025-00259).