BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 1905757 · Received November 17, 2010

    Report

    Report Number
    1219930-2010-00883
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 24, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Adverse Event
    Yes
    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: THE DEVICE WAS DULL AND WOULD NOT CUT TISSUE SMOOTHLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES SINCE IT TOOK TIME TO CUT TISSUE. NO ADDITIONAL PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL N0F0593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other