NA

Description of Event or Problem

RWGMBH REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION: (SEE H10).

Additional Manufacturer Narrative

FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH DEVICE EVALUATION RESULTS. NEW INFORMATION: B4, B5, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H7, AND H10. THE REPORTED DEVICE WAS RECEIVED BY RICHARD WOLF GMBH FOR INVESTIGATION ON 10/12/2022. THE CUSTOMER HAS RETURNED 2 PIECES OF TROCAR SLEEVE CAP 2.2MM WL 60MM. ONLY ONE OF THEM IS BROKEN. BOTH DEVICES WERE INSPECTED IN THE RESPONSIBLE DEPARTMENT. NO SIGNS OF MATERIAL OR PRODUCTION FAILURE WERE DISCOVERED. IT SEEMS THAT THE TROCAR SLEEVE WAS NOT INSERTED COMPLETELY AND THE TROCAR SLEEVE WAS BROKEN DUE TO MECHANICAL OVERLOAD. BOTH TROCAR SLEEVE CAP 2.2MM WL 60MM IS FROM THE BATCH #13227714. THE BATCH WAS PRODUCED ON 07/07/2016. THE AFFECTED CUSTOMER HAS RECEIVED IN TOTAL 3 PIECES FROM THIS BATCH: - 05/17/2017 - 1 PIECE - 03/17/2021 - 2 PIECES THERE ARE NO FURTHER COMPLAINTS REGARDING THE TROCAR SLEEVE CAP 2.2MM WL 60MM NEITHER FROM THE SAME BATCH NOR FROM OTHER BATCH IN THE REVIEW PERIOD OF 01/01/2019 - 10/06/2022. THE USER IS ADVISED IN THE RELEVANCE IFU GA-B 147 / USA / 2012-02 V1.0 / ECO 2012-0159 ABOUT THE LIMITED STRENGTH OF THE DEVICE IN SECTION 6 APPLICATION AS WELL AS ABOUT THE INJURY RISK OF THE PATIENT IF THE TROCAR IS NOT CORRECTLY INSERTED INTO THE TROCAR SLEEVE IN SECTION 6.1 PREPARATION. IN THE RISK ASSESSMENT D2 -REUSABLE TROCARS, TROCAR SLEEVES AND CANNULAS, REV.: R02, THE POSSIBLE RISK DUE TO FAILURE OF THE CORRESPONDING EXTEND OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE AND PROBABILITY OF RE-OCCURRENCE WERE CONSIDERED AND ASSESSED AS AN ACCEPTABLE RISK.

Description of Event or Problem

RWGMBH REFERENCE COMPLAINT NO. (B)(4). THE USER FACILITY HAS REPORTED THE FOLLOWING ON 10/10/2022: "MINI LAPAROSCOPY:" INSERTION OF THE ACCESS (MINI-TROCAR, PLASTIC) IN THE RIGHT UPPER ABDOMEN FOR THE BIOPSY ON THE RIGHT. AFTER COMPLETE INSERTION, DURING MANIPULATION TO CORRECT THE ORIENTATION OF THE MINI-TROCAR THE PLASTIC MINI-TROCAR BREAKS OFF CLOSE TO THE HEAD, LEAVING A PORTION OF THE TROCAR IN THE SUBCUTANEOUS ADIPOSE TISSUE WITH A SHORT INTRAPERITONEAL STUMP. THE APPROXIMATELY WIDER PROXIMAL HEAD SECTION THAT HAS BROKEN OFF REMAINS BETWEEN THE EXAMINER'S FINGERS. THE SHORT INTRAPERITONEAL SEGMENT (APPROXIMATELY 2CM) IS FIXED WITH THE LONG SCISSORS. RETRIEVAL OF THE BROKEN SEGMENT CAN BE ACCOMPLISHED BY WIDENING THE SKIN INCISION WITH SURGICAL FORCEPS. INTRAPERITONEAL NO BLEEDING, NO COMPLICATIONS". RWGMBH MDR AWARENESS DATE: 10-OCT-2022

Additional Manufacturer Narrative

RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH (MANUFACTURER). THE REPORTED DEVICE WAS RECEIVED BY RICHARD WOLF GMBH FOR INVESTIGATION ON 10/12/2022. RICHARD WOLF GMBH CONSIDERS THIS MATTER OPEN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.