BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2120472 · Received June 3, 2011

    Report

    Report Number
    1219930-2011-00483
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 10, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Adverse Event
    Yes
    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

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE DEVICE WAS SEALING BUT NOT CUTTING. A NOISE WAS NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE TWEEZERS WAS OSCILLATING. OPERATIVE TIME WAS EXTENDED MORE THAN THIRTY MINUTES TO DETECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL N0D0115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other