BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2440447 · Received January 31, 2012

    Report

    Report Number
    MW5024112
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    December 7, 2011
    Report Date
    January 31, 2012
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE INSTRUMENT WAS BEING TESTED, THE GENERATOR SHOWED "TIGHTEN INSTRUMENT." THE SCRUB TECH TIGHTENED THE INSTRUMENT AND THE GENERATOR SHOWED "ERROR." THE FAULTY INSTRUMENT WAS REPLACED BY ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY LLC HARMONIC ACE GDW ETHICON ENDO SURGERY 1702094 STRYKER/ASCE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR