BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC AC SHEARS, 5MM, 36CM

    MDR report key: 5155788 · Received October 8, 2015

    Report

    Report Number
    MW5057054
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    STRYKER SUSTAINABILITY SOLUTIONS, HAR 36, HARMONIC ACE SHEARS WOULD NOT FUNCTION. A SECOND "LIKE" DEVICE WAS OPENED/ASSEMBLED AND UTILIZED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670290 HARMONIC AC SHEARS, 5MM, 36CM HARMONIC SCALPEL LFL STRYKER SUSTAINABILITY SOLUTIONS HAR36 3848242

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR