BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1481624 · Received September 17, 2009

    Report

    Report Number
    MW5012814
    Event Type
    Injury
    Date Received
    September 17, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 17, 2009
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPROCESSED LAPAROSCOPIC BABCOCK GRASPER LOCKING MECHANISM REPEATEDLY FAILED AFTER SETTING. RESULTED IN DISRUPTION OF SURGERY AND ADDITIONAL TISSUE TRAUMA WITH EACH FAILURE. WAS BEING USED IN LAPAROSCOPIC APPENDECTOMY TO HOLD THE APPENDIX, BUT KEPT POPPING OFF. DATES OF USE: 2009 - 10 MINUTES. DIAGNOSIS OR REASON FOR USE: ACUTE APPENDICITIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON BABCOCK GRASPER 10MM; 32CM GCJ ASCENT HEALTHCARE SOLUTIONS 173240
    2 ETHICON BABCOCK GRASPER 10MM; 32CM GCJ ASCENT HEALTHCARE SOLUTIONS 173240

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability