BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 1519991 · Received October 29, 2009

    Report

    Report Number
    MW5013215
    Event Type
    Malfunction
    Date Received
    October 29, 2009
    Date of Event
    October 27, 2009
    Report Date
    October 28, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE HARMONIC SCALPEL, THE MACHINE KEPT SHUTTING OFF. HARMONIC SCALPEL WAS NOT WORKING. NOTED THAT A PIECE OF THE SCALPEL GRASPER WAS MISSING. NEGATIVE X-RAY. REPLACED ACE HARMONIC SCALPEL AND PATIENT DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC HARMONIC ACE GDX ETHICON ENDO-SURGERY, LLC P30223P02 FYPH182014-08

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR