BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCELVEEN-HITSELBERGER NEURAL DISSECTOR KNIFE

    MDR report key: 10189082 · Received June 23, 2020

    Report

    Report Number
    MW5095168
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 19, 2020
    Manufacturer
    MIZUHO AMERICA, INC
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF MCELVEEN KNIFE BROKE OFF. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646742 MCELVEEN-HITSELBERGER NEURAL DISSECTOR KNIFE INSTRUMENT, SURGICAL, NON-POWERED HAO MIZUHO AMERICA, INC CP-12-90

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other