BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2760398 · Received September 18, 2012

    Report

    Report Number
    1219930-2012-00767
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 3, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    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 TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: CUTTING ABILITY OF THE DEVICE WAS APPARENTLY POOR. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING, NO TISSUE DAMAGE, NO ADDITIONAL TISSUE LOSS, NOTHING FELL INTO CAVITY. OPERATIVE TIME WAS NOT EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL COVIDIEN, FORMERLY US N1M0483X

    Patients

    Seq Age Sex Outcome Treatment
    1