BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1481625 · Received September 17, 2009

    Report

    Report Number
    MW5012815
    Event Type
    Malfunction
    Date Received
    September 17, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 17, 2009
    Manufacturer
    ASCENT
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPROCESSED ETHICON BABCOCK GRASPER HAS DIFFERENT IDENTIFICATION NUMBERS ON PACKAGING THAN ON INSTRUMENT ITSELF. DATES OF USE: 2009 - 10 MINUTES. DIAGNOSIS OR REASON FOR USE: ACUTE APPENDICITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR