SILICONE RING WITH NEEDLE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCTS WERE NOT PROVIDED FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON ANALYSIS OF HISTORICAL DATA REVIEW, DEVICE HISTORY RECORDS, AND REVIEW OF EVENT INFORMATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS 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. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER 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: IN LIGHT OF THE LITTLE INFORMATION RECEIVED AND WITHOUT THE PRODUCT IT IS NOT POSSIBLE TO DETERMINE AN EXACT ROOT CAUSE FOR THE MENTIONED FAILURE. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT 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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT PL595SU - SILICONE RING WITH NEEDLE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE GRAY SILICONE RING SNAPPED AND BROKE IN HALF WHILE RETRACTING THE GALLBLADDER. THE BROKEN RING FELL ON THE PATIENT'S GALLBLADDER WITH THE CLIP ATTACHED AND WAS RETRIEVED WITH A GRASPER. FLUOROSCOPY WAS NOT REQUIRED FOR REMOVAL. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. 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. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.