BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 3022809 · Received March 21, 2013

    Report

    Report Number
    MW5029482
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HARMONIC BLACK CLAMP UNABLE TO TIGHTEN AND NOT USEABLE. REQUIRED SECOND HORMONIC TO BE OPENED AND CASE RESUMED. PHYSICIAN AWARE. ALSO UNABLE TO ROTATE AT BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118014 ETHICON HARMONIC SHEARS ACE LAPAROSCOPIC LFL ETHICON HAR36 K90862

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR