SILICONE RING WITH NEEDLE

Additional Manufacturer Narrative

ASSOCIATED MEDWATCH REPORTS: PL595SU - 400530801 (9610612-2021-00683), PL595SU - 400530802 (9610612-2021-00684). INVESTIGATION: VISUAL INVESTIGATION: THE ANALYSIS OF THE DAMAGE PATTERN SHOWS A FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND AT THT DAMAGE SITE. BATCH 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. THERE ARE 2 SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S). THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 6(10) X PROBABILITY OF OCCURRENCE 3(10)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: BASED ON THE DAMAGE PATTERN, THE BREAKAGE OF THE SILICONE RING WAS MOST LIKELY CAUSED BY OVERLOAD BY PULLING BEYOND YIELD STRENTH. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE ON THE BASIS OF THE DEVICE HISTORY RECORDS. BASED ON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED TO AESCULAP AG THA A SILICONE RING WITH NEEDLE (PART # PL595SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT THE SILICONE RING WAS TORN. REPORTEDLY, THE CUSTOMER HELD THE NEEDLE AND SET IT, BUT THE SILICONE RING TORE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00683 (400530801 PL595SU). 9610612-2021-00684 (400530802 PL595SU).