BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 1157594 · Received September 3, 2008

    Report

    Report Number
    1219930-2008-00658
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Report Date
    August 28, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SUBMITTED: 09/03/2008.

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING USE THE DEVICE DID NOT SEAL PROPERLY AND IT COULD NOT HOLD TISSUE. ANOTHER ULTRA SHEARS WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT ENERGY DEVICE LFL NORTH HAVEN - USS N7D342

    Patients

    Seq Age Sex Outcome Treatment
    1