BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE

    MDR report key: 3131164 · Received May 22, 2013

    Report

    Report Number
    MW5030285
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL STOPPED WORKING DURING CASE. MONITOR SAID CHECK BLADE AND REMOVE INSTRUMENT. HANDPIECE REPLACED. REASON FOR USE: LAPAROSCOPIC PELVISCOPY WITH MYOMECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227370 HARMONIC ACE SHEARS, ERG HANDLE, CURVED BLADE HARMONIC SCALPEL, 5.5 DIA, 36 CM LFL STRYKER SUSTAINABILITY SOLUTIONS ACE36E 2453444

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR