BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2133260 · Received May 11, 2011

    Report

    Report Number
    1219930-2011-00372
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE TIP OF THE INSTRUMENT BROKE AFTER A FEW MINUTES OF USE. THE TIP WAS RECOVERED EASILY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL N0F0065

    Patients

    Seq Age Sex Outcome Treatment
    1