BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2133718 · Received June 9, 2011

    Report

    Report Number
    1219930-2011-00477
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 25, 2011
    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 TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: WHEN THE DEVICE WAS SQUEEZED, THE TIP WOULD NOT OPEN. ANOTHER DEVICE WAS USED. OOZING OCCURRED. OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL UNITED STATES SURGICAL N1B0069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other