BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3070352 · Received April 17, 2013

    Report

    Report Number
    2134070-2013-00090
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K120040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE JAWS OF THE DEVICE STUCK CLOSED. UPON EVALUATION IT WAS FOUND THAT THE BLADE WAS EXTENDED, HAD MOVED OUT OF THE GUIDING FEATURE, AND WAS PROTRUDING LATERALLY OUT OF THE BOTTOM OF THE JAWS. THE HANDLE DID LATCH AND UNLATCH AS INTENDED, BUT THE JAWS REMAINED STUCK CLOSED. 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 PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYNECOLOGIC PROCEDURE THE FIRST DEVICE LOCKED ON TISSUE. ANOTHER DEVICE WAS USED AND IT ALSO LOCKED ON TISSUE. IT WAS NOT REPORTED HOW THE DEVICES WERE REMOVED. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THIS REPORT IS BEING FILED FOR THE FIRST DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MFR REPORT NUMBER 2134070-2013-00091 REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166993 NA NUJ STERILMED, INC. COVLF4200 1621815

    Patients

    Seq Age Sex Outcome Treatment
    1