BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRAUMATIC BOWEL GRASPER

    MDR report key: 6961764 · Received October 19, 2017

    Report

    Report Number
    1418479-2017-00029
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    RICHARD WOLF GERMANY (RWGMBH)
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS COOPERATION (RWMIC) WAS CONTACTED BY HOSPITAL AND THEY REPORTED THAT DURING A PROCEDURE THE GRASPER BROKE OFF INSIDE OF PATIENT. FACILITY INDICATED THEY WERE ABLE TO RETRIEVE ALL PIECES THAT FELL ONTO PATIENT. A BACK UP DEVICE WAS READILY AVAILABLE FOR USE WITH MINIMAL DELAY TO PROCEDURE. PROCEDURE COMPLETED AS SCHEDULED. NO INJURY TO PATIENT OR STAFF REPORTED. DEVICE APPROXIMATELY 4 YEARS OLD, NO UDI NUMBER ASSOCIATED WITH DEVICE. FACILITY HAS BEEN CONTACTED, VIA EMAIL, IN AN EFFORT TO GATHER ADDITIONAL/MISSING FOR MEDWATCH REPORT. NO RESPONSE RECEIVED AS OF 19OCT2017. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE LAST FIVE YEARS FOR THIS DEVICE (ID #83934946). INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: 6 USE CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. DUE TO THE SMALL DIMENSIONS REQUIRED, THE PRODUCTS HAVE ONLY LIMITED STRENGTH. USE THESE PRODUCTS ONLY TO GRASP AND ABLATE SMALL, SOFT TISSUE PORTIONS OR ORGANS. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING PARTS REMAIN IN THE PATIENT. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. SEVEN CHECKS CAUTION! BE CAREFUL IF PRODUCTS ARE DAMAGED OR INCOMPLETE! INJURIES OF THE PATIENT, USER OR OTHERS ARE POSSIBLE. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. A 7.1 VISUAL CHECK CAUTION! DAMAGED SURFACE IN THE JOINT AREA OF THE FORCEPS! THE JOINT PIN MAY LOOSEN. CHECK FOR SURFACE CHANGES SUCH AS HAIR CRACKS ETC. AT THE HINGE PIN. DEVICE HAS NOT BEEN RETURNED. IF RWMIC RECEIVES DEVICE, IT WILL BE SENT TO MANUFACTURER FOR INVESTIGATION. RWMIC CONSIDERS THIS REPORT CLOSED. IF RWMIC RECEIVES ADDITIONAL INFORMATION REGARDING THIS INCIDENT, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741633 ATRAUMATIC BOWEL GRASPER ATRAUMATIC GRASPER GCJ RICHARD WOLF GERMANY (RWGMBH) 83934946 1207690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other