BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2491815 · Received March 9, 2012

    Report

    Report Number
    2134070-2012-00009
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Report Date
    February 13, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K012679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION DETERMINED THAT THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS FUNCTION TESTED AND PASSED THE AUTOMATED RF PROBE FUNCTION TESTS. INSPECTION OF THE DEVICE SHOWED THAT THE DEVICE HAD BEEN USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF A SHOULDER THE RF PROBE WAS PLUGGED IN A CRACKLING NOISE COULD BE HEARD WHEN THE HEALTH CARE PROFESSIONAL PRESSED THE PEDAL AND SPARKS CAME FROM THE TIP. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT TO BE USED NOR DID IT COME INTO CONTACT WITH THE PATIENT. A NEW DEVICE WAS USED WITHOUT ANY PROBLEM. THE SURGERY DID TAKE EXTRA TIME, HOWEVER, IT WAS NOT CLEAR WHETHER THIS WAS DUE TO THE ISSUE WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NUJ - RF PROBE NUJ STERILMED, INC. ARTASC5000-01

    Patients

    Seq Age Sex Outcome Treatment
    1