PURSE STRING CLAMP

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY ATS. THE MOVEMENT OF THE CLAMP WITH THE LABELING (B)(4) IS A LITTLE BIT TOO SMOOTH. THE CORRECT FUNCTION IS STILL GIVEN, THE INSTRUMENT IS WORKING. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: ACCORDING TO THE INVESTIGATION OF ATS, THE INSTRUMENTS ARE WORKING. THUS IS CAN EXCLUDE A MATERIAL OR MANUFACTURING CAUSED ERROR. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE FORCEPS (PURSE STRING CLAMP WAS USED FOR SURGERY. THE SUTURE DID NOT HOLD, THE FORCEPS DID NOT FUNCTION PROPERLY. NEW OPERATION WAS NECESSARY DUE TO LESION. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00177, 9610612-2017-00185. INCIDENT WAS REPORTED BY THE SAME INITIAL REPORTER BY MDRS: 9610612-2017-00083 AND 9610612-2017-00093. ITS UNKNOWN IF THESE WERE USED ON THE SAME PATIENT WITH INFORMATION REPORTED.