BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2823506 · Received October 8, 2012

    Report

    Report Number
    1219930-2012-00811
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    August 10, 2012
    Report Date
    September 24, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURG
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING THE PEELING OFF OF THE THICK FAT TISSUE AROUND THE KIDNEY, THE DEVICE BECAME INOPERATIVE. AFTER A WHILE, THE SURGEON TRIED AGAIN, BUT THE DEVICE STILL COULD NOT BE USED. A NEW DEVICE WAS OPENED, BUT THE SAME TROUBLE OCCURRED. USING A THIRD DEVICE, THE PROCEDURE WAS COMPLETED. NO BLEEDING. NO TISSUE DAMAGE. NO ADDITIONAL TISSUE LOSS. NOTHING FELL INTO CAVITY. NO PT HARM. OPERATING ROOM TIME NOT EXTENDED BY MORE THAN 30 MINUTES. ADDITIONAL INFO - ABOUT US201209-0484, THE GRIP FORCE BECAME WEAK AND THE BLADE SLID SIDEWAYS WHILE ACTIVATION. THAT IS WHY THE SURGEON STOPPED USING IT AND OPENED NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL COVIDIEN, FORMERLY US SURG N1L0782X

    Patients

    Seq Age Sex Outcome Treatment
    1