BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE SHEARS, 5MM, 36CM

    MDR report key: 6140683 · Received November 30, 2016

    Report

    Report Number
    MW5066450
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    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

    STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE SHEARS "MIN" BUTTON NOT FUNCTIONING. EXCHANGED FOR "LIKE" DEVICE WHICH FUNCTIONED WITHOUT ISSUE. DIAGNOSIS OR REASON FOR USE: TOTAL LAPAROSCOPIC HYSTERECTOMY, LSO, A/P REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787219 HARMONIC ACE SHEARS, 5MM, 36CM HARMONIC SCALPEL LFL STRYKER SUSTAINABILITY SOLUTIONS HAR36 4217796

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR