BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3791819 · Received January 22, 2014

    Report

    Report Number
    2134070-2014-00022
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 19, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K123096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE JAWS LOCKED SHUT. THE JAWS WERE IN ALIGNMENT AND THE BLADE WAS FULLY RETRACTED. UPON EVAL, THE MAIN HANDLE WAS UNABLE TO UNLOCK THE JAWS. THE BLADE WAS ABLE TO ACTUATE AND RELEASE FREELY. ELECTRICAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO RELEASE, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY THE DEVICE WAS NOT CAUTERIZING THE TISSUE, AND THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED WITH THE JAWS STUCK CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53499 NA NUJ STERILMED, INC. COVLF1537 1633981

    Patients

    Seq Age Sex Outcome Treatment
    1