BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2191709 · Received July 1, 2011

    Report

    Report Number
    1219930-2011-00538
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 23, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: CUTTING WAS DULL. ANOTHER DEVICE WAS USED. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE WAS DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL N1B0069

    Patients

    Seq Age Sex Outcome Treatment
    1