BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3123983 · Received May 15, 2013

    Report

    Report Number
    2134070-2013-00108
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K120040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE HANDLE IN THE LOCKED POSITION AND A LARGE AMOUNT OF TISSUE IN BETWEEN THE JAWS. THE JAWS WERE NOT FULLY CLOSED AND WERE OUT OF ALIGNMENT. UPON EVAL, IT WAS FOUND THAT THE JAWS COULD NOT BE OPENED. THE HANDLE WAS ABLE TO MOVE, BUT DID NOT HAVE A FULL RANGE OF MOTION AND DID NOT ACTUATE THE JAWS. THE BLADE WAS EXTENDED, BUT FULLY CONTAINED WITHIN THE JAWS. IT ALSO WAS NOTED THAT THE SHAFT WAS DIFFICULT TO ROTATE. ELECTRICAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE: DO NOT OVERFILL THE JAWS OF THE INSTRUMENT WITH TISSUE. THIS MAY DAMAGE THE CUTTING MECHANISM OR CAUSE THE BLADE TO DEPLOY OUTSIDE OF ITS GUIDING FEATURES, POSSIBLY RESULTING IN DIFFICULTY OPENING THE JAWS OR UNINTENDED INJURY TO THE USER OR PT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CYSTECTOMY THE DEVICE LOCKED ONTO TISSUE, WOULD NOT OPEN OR CUT TISSUE. THE CUTTING MECHANISM WOULD NOT "UNCOIL." THE PROCEDURE WAS DELAYED. THERE WAS NO PT INJURY. ADD'L INFO RECEIVED UPON INQUIRY INDICATED THAT THE DEVICE WAS PRIED AND PULLED OFF OF THE TISSUE. THE DELAY WAS 10 MINUTES. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214648 NA NUJ STERILMED, INC. COVLF4200 1562040

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR