BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM -LONG-

    MDR report key: 2240774 · Received September 1, 2011

    Report

    Report Number
    MW5022128
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 1, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC REMOVAL AND REPLACEMENT OF GASTRIC BANDING, HIATAL HERNIA REPAIR, THE AUTOSONIX ULTRA SHEARS TIP BROKE. TIP RETRIEVED FROM ABDOMEN INTACT. COMPANY REP NOTIFIED. TO BE RETURNED TO COVIDIEN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM -LONG- AUTOSONIX ULTRA SHEARS LFL UNITED STATES SURGICAL 012033 N1C1094

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability