BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SONIX

    MDR report key: 456995 · Received April 28, 2003

    Report

    Report Number
    MW1028277
    Event Type
    Malfunction
    Date Received
    April 28, 2003
    Date of Event
    April 24, 2003
    Report Date
    April 28, 2003
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC RADICAL NEPHRECTOMY, TIP BROKE OFF ULTRA SHEARS WHILE BEING USED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SONIX ULTRA SHEARS LFL UNITED STATES SURGICAL 5MM LONG N3B175

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR