BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 1940445 · Received December 9, 2010

    Report

    Report Number
    1219930-2010-00931
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 16, 2010
    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

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, CUTTING COULD NOT BE DONE PROPERLY. 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 ACCESSORY LFL UNITED STATES SURGICAL N0F0065

    Patients

    Seq Age Sex Outcome Treatment
    1