BEUDAMED
    FDA Adverse Event Other Summary report: N

    J&J HARMONIC SCALPEL

    MDR report key: 6215315 · Received December 27, 2016

    Report

    Report Number
    MW5066980
    Event Type
    Other
    Date Received
    December 27, 2016
    Date of Event
    September 15, 2016
    Report Date
    December 27, 2016
    Manufacturer
    ETHICON
    Product Code
    HGI
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL USED AND PLACED ON DRAPE. SCRUB PERSONNEL ASKED IF INSTRUMENT PERFORMING APPROPRIATELY AS HAD BURN MARK ON DRAPE WHERE DEVICE WAS PLACED. UPON INSPECTION OF DEVICE WAS NOTED TO HAVE A PLASTIC PORTION MISSING. DEVICE WAS REMOVED FROM THE FIELD AND REPLACED. DAMAGED DEVICE WAS RETAINED PER PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857869 J&J HARMONIC SCALPEL EES GENERATOR HGI ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR