KELLY FORCEPS DEL CVD 140MM

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. 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 - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING 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. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

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 A HEMOSTAT VIA INFORMATION RECEIVED FROM MEDSUN 2025-2_FDA6. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING THE COLLECTION OF INSTRUMENTS FOR CLOSURE, THE TIP OF THE CRILE HEMOSTATIC FORCEPS BROKE WHILE THE SURGICAL TECHNICIAN WAS UNCLAMPING OFF THE SURGICAL SITE. AN X-RAY WAS PERFORMED AND RESULTS CONFIRMED THAT THERE WERE NO FRAGMENTS IN SITU. 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 - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO.(B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A SECTION - PATIENT DATA. B5 - DESCRIPTION UPDATED. D1&D2 - BRAND NAME, PRODUCT CODE. D4 - MATERIAL, BATCH AND SERIAL NUMBER. E1 - REPORTER ADDRESS. E2 - PROFESSION. G4 - 510K. H4 - MANUFACTURE DATE. H10 - RELATED REPORT NUMBERS.

Description of Event or Problem

UPDATE: PRODUCT CODE WAS UPDATED TO BH135R - KELLY FORCEPS DEL CVD 140MM. MEDSUN FDA REPORT (B)(4) WAS RECEIVED. THE EVENT OCCURRED IN (B)(6) 2025 DURING THE PROCEDURE CREATION OF LEFT BRACHIAL ARTERY TO LEFT AXILLARY VEIN ARTERIOVENOUS GRAFT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: BASED ON THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. EVEN AFTER GOOD FAITH ATTEMPTS FOR RETRIEVAL, NO FURTHER INFORMATION COULD BE RECEIVED. ACCORDING TO THE MANUFACTURER´S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASONS: ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/ PREVENTIVE MEASURES: DUE TO THE LACK OF DATA AND WITHOUT THE COMPLAINT SAMPLE BEING AVAILABLE FOR INVESTIGATION, A DEFINITE ROOT CAUSE FOR THE REVISION CANNOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING, OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.