BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RATCHETED HANDLE

    MDR report key: 8591273 · Received May 8, 2019

    Report

    Report Number
    9681129-2019-00001
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BEMA GMBH & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K102921
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER RETURNED SEVERAL RATCHETED HANDLES, BOTH NEW AND USED. THE RATCHET ENGAGES SMOOTHLY, AS INTENDED, ON SOME OF THE RETURNED USED HANDLES. ON THE REMAINING USED HANDLES, THE RATCHET STICKS SLIGHTLY, AS IF INSUFFICIENTLY LUBRICATED. HOWEVER, THE RATCHET STILL FUNCTIONS CORRECTLY, CAN BE ENGAGED MANUALLY, AND IS EASILY RELEASED TO OPEN THE GRASPER TIP OF THE DEVICE. IT IS NOT CLEAR WHETHER THE DEVICE INVOLVED IN THE EVENT WAS RETURNED, SINCE IT WAS NOT MARKED BY THE USER. IF IT WAS RETURNED, IT IS NOT CLEAR WHETHER IT BELONGED TO THE GROUP OF RETURNED HANDLES WITH SMOOTHLY ENGAGING RATCHET, OR TO THE GROUP OF HANDLES ON WHICH THE RACHET MECHANISM NEEDED TO BE ENGAGED MANUALLY. INSPECTION OF ALL OF THE RETURNED HANDLES SHOWED THAT THE GRIPPING AND RELEASING FUNCTION OF THE HANDLE WORKED CORRECTLY ON ALL OF THEM. REGRIPPING TISSUE MULTIPLE TIMES WOULD NOT HAVE BEEN NECESSARY TO ADEQUATELY GRASP AND MANIPULATE TISSUE. REGRIPPING THE TISSUE MULTIPLE TIMES CAN BE QUALIFIED AS USER ERROR. IN ADDITION, IN ACCORDANCE WITH EXPERT MEDICAL OPINION SOUGHT OUT BY THE MANUFACTURER, NO CAUSAL LINK CAN BE ESTABLISHED BETWEEN THE COMPLICATIONS SUFFERED BY THE PATIENT AND THE USER ERROR OF REGRIPPING THE TISSUE MULTIPLE TIMES, DUE TO THE CONSIDERABLE DELAY EXISTING BETWEEN THE DATE OF THE EVENT, RELEASE OF THE PATIENT FROM THE HEALTHCARE FACILITY AND THE ONSET OF COMPLICATIONS, AMONG OTHER REASONS. MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN APPENDECTOMY, THE SURGEON ATTEMPTED TO GRASP THE APPENDIX WITH A GRASPER PROVIDED WITH A RATCHET HANDLE. THE RATCHET DID NOT ENGAGE AUTOMATICALLY. THE SURGEON REGRIPPED THE APPENDIX MULTIPLE TIMES. EVENTUALLY, THE APPENDIX WAS PERFORATED. HOWEVER, THE CASE WAS COMPLETED SATISFACTORILY AND THE PATIENT WAS RELEASED. AFTER HAVING BEEN RELEASED, THE PATIENT WENT SEPTIC AND WAS READMITTED TO THE HOSPITAL DUE TO FORMATION OF AN ABSCESS. A PERCUTANEOUS DRAIN WAS PLACED AND THE PATIENT WAS RELEASED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384438 RATCHETED HANDLE MODULAR HANDLE GEI BEMA GMBH & CO. KG 67414

    Patients

    Seq Age Sex Outcome Treatment
    1 Other