SILICONE RING WITH NEEDLE

Additional Manufacturer Narrative

INVESTIGATION RESULTS AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. 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-, 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 INVESTIGATIONS 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 THAT A SILICONE RING WITH NEEDLE (PART # PL595SU) WAS USED DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SILICONE RINGS OF THE DEVICE WERE TORN. REPORTEDLY, WHILE REMOVING THE HOOK NEEDLE FROM THE ABDOMINAL WALL BEFORE THE END OF SURGERY, THE SILICONE RUBBER BROKE AND THE HOOK NEEDLE FELL INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS RECOVERED FROM THE PATIENT'S BODY USING X-RAY. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED. THE SURGERY TIME POSSIBLY EXTENDED DUE TO INTRA OPERATIVE X-RAY EXAMINATION TO SEARCH FOR THE NEEDLE IN THE OPERATIVE FIELD. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).