BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2112221 · Received April 29, 2011

    Report

    Report Number
    1219930-2011-00358
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 10, 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: BY PREPARATION FOR SURGERY, THE FORCE TO GRASP TISSUE WAS WEAR AND THE CUTTING WAS DULL. THE DEVICE WAS NOT USED ON THE PATIENT. 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 N1A0423

    Patients

    Seq Age Sex Outcome Treatment
    1