BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND KNIFE

    MDR report key: 4613491 · Received March 12, 2015

    Report

    Report Number
    MW5041491
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 10, 2015
    Report Date
    March 12, 2015
    Manufacturer
    AMBLER SURGICAL
    Product Code
    JYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A RIGHT TYMPANOMASTOIDECTOMY, WHILE PUTTING THE ROUND KNIFE INTO THE PT'S EAR, THE KNIFE BROKE IN TWO PIECES AND THE BROKEN PIECES OF THE ROUND KNIFE WERE RECOVERED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169893 ROUND KNIFE ROUND KNIFE JYO AMBLER SURGICAL 39-500

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR