BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC GOLD 21-1020 PIN CUTTER

    MDR report key: 5747734 · Received June 24, 2016

    Report

    Report Number
    5747734
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    April 1, 2016
    Report Date
    June 15, 2016
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE CUTTING KWIRE, THE CUTTING EDGE OF CUTTER BROKE. NO ADVERSE COMPLICATIONS TO PATIENT. PIECES RETRIEVED AND WOUND CLEANED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402685 TC GOLD 21-1020 PIN CUTTER INSTRUMENT, SURGICAL, NON-POWERED HAO NATIONAL ADVANCED ENDOSCOPY DEVICES, INC 21-1052

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR