BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE SHEARS, 5MM X 36CM

    MDR report key: 6313809 · Received February 7, 2017

    Report

    Report Number
    MW5067762
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 7, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    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 WOULD NOT TIGHTEN TO CORD. REASON FOR USE: LAPAROSCOPIC HYSTERECTOMY, BSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92596 HARMONIC ACE SHEARS, 5MM X 36CM HARMONIC SCALPEL NLQ STRYKER SUSTAINABILITY SOLUTIONS HAR36 4934277

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR