BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAR-H36

    MDR report key: 6140684 · Received November 30, 2016

    Report

    Report Number
    MW5066451
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WHITE PAD ON HARMONIC SHEAR SEPARATED WHILE INSIDE A PT. ALL PIECES WERE RECEIVED. ETHICON REP IN THE ROOM WHEN THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787220 HAR-H36 HARMONIC SCALPEL NLQ ETHICON ENDO SURGERY HAR-H36 N91DIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR