BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3791817 · Received January 22, 2014

    Report

    Report Number
    2134070-2014-00023
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 3, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    PMA / PMN Number
    K050343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD DETACHED AND NOT RETURNED WITH THE DEVICE. UPON EVAL, THE DEVICE DISPLAYED AN ERROR CODE DURING A SELF-TEST WHEN CONNECTED TO THE GENERATOR. 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 LAPAROSCOPIC COLECTOMY WHEN THE DEVICE WAS PLUGGED IN, IT "CAME UP" AS AN ERROR CODE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53265 NA NLQ STERILMED, INC. ETHACE36E 1697408

    Patients

    Seq Age Sex Outcome Treatment
    1