BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERAGON MODULAR

    MDR report key: 10244774 · Received July 8, 2020

    Report

    Report Number
    9611102-2020-00010
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 19, 2020
    Report Date
    June 30, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    UDI-DI
    04055207026625
    PMA / PMN Number
    K935270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH ADDITIONAL INFORMATION. THE FOLLOWING FIELDS HAVE NEW AND/OR CHANGE INFORMATION : D4, G7, H1, H2, H3, H6, H7, H8, H10. THE USER REPORT POINTS OUT THAT DURING THE APPLICATION IT WAS NO LONGER POSSIBLE TO OPEN THE HANDLE AND THEN OPEN THE PLIERS. THIS SCENARIO COULD NOT BE SIMULATED (DURING THE TEST). THE CUSTOMER'S INSTRUMENTATION, CONSISTING OF: 83930074 HAND HANDLE PISTOL MONO LOT 1448940 HAS BEEN CHECKED IN THE RESPONSIBLE DEPARTMENT. INSTRUMENT HAS NO DEFECTS. IF THE HANDLE LEGS ARE SQUEEZED EXTREMELY HARD WHEN THE LOCK IS SWITCHED ON, A GREATER FORCE MUST ALSO BE APPLIED WHEN THE LOCK IS SWITCHED OFF. THE HANDLE PISTOL SHAPED MONO FROM BATCH 1448940 WAS BOOKED TO THE SALES WAREHOUSE ON 15.05.2020. PRODUCTION ORDER 1448940 CONSISTS OF (B)(4) PIECES. THE HANDLE PISTOL SHAPED MONO 83930074 HAS BEEN IN THE PROGRAM SINCE 04.05.2011. THE COMPLAINTS DATABASE WAS EXAMINED IN THE PERIOD 01.01.2017 TO 19.06.2020. DURING THIS PERIOD 18236 PIECES OF THE HANDLE PISTOL SHAPED MONO 83930074 WERE SOLD. AT THE SAME TIME 9 HANDLE PISTOL SHAPED MONO WERE CLAIMED. ACCORDING TO THE ERAGON MODULAR /AXIAL PLIERS SCISSORS AND HANDLES, GA-S 027 / EN / 2015-06 V7.0 / ÄM: PDZ 15-8028 IN CHAPTER 7, THE USER IS INFORMED THAT -EXCESSIVE USE OF FORCE CAN LEAD TO BREAKAGE OR DAMAGE TO THE PRODUCTS - DUE TO THE REQUIRED SMALL DIMENSIONS THE PRODUCTS HAVE ONLY LIMITED STABILITY - THE PRODUCTS ARE INTENDED TO GRIP AND REMOVE ONLY SMALL, SOFT TISSUE/ORGANS - FOR THERAPEUTIC APPLICATIONS WE RECOMMEND KEEPING A REPLACEMENT INSTRUMENT AVAILABLE. THE GRIPPER HAS BEEN TESTED IN HOUSE. THE CATCH COULD EITHER BE DEACTIVATED WITH THE LOCKING LEVER (3.4) OR THE CATCH COULD BE DISENGAGED WITH THE TRIGGER (3.5). FROM OUR POINT OF VIEW, THIS IS A USER ERROR. NO DEFECTS WERE FOUND ON THE PRODUCT. POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT B1-2 R02 (REUSABLE NON-OPTICAL PLIERS AND SCISSORS) WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND WERE EVALUATED WITH AN ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN TAKING INTO ACCOUNT THE CURRENT CASE. RICHARD WOLF GMBH(RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION(RWMIC) IS SUBMITTING THIS REPORT ON BEHALF OF RWGMBH.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE DEVICE IS IN PROGRESS. THE DEVICE IS CURRENTLY BEING RETURNED BY THE USER TO RICHARD WOLF (B)(4), AND A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED: THE HANDLES DO NOT OPEN/CLOSE RELIABLY (OCCURS REPEATEDLY)IN ONE PATIENT, THE HANDLE COULD NOT BE OPENED WHEN THE TISSUE WAS GRASPED ON THE JAW SIDE, SO THAT AN EMERGENCY THORACOSCOPY ALMOST BECAME NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711182 ERAGON MODULAR HANDLE PISTOL SHAPED MONOPOLAR GCJ RICHARD WOLF GMBH 83930074 1448940 04055207026625

    Patients

    Seq Age Sex Outcome Treatment
    1 Other