BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3080943 · Received April 24, 2013

    Report

    Report Number
    2134070-2013-00093
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K052299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION, AN OBTURATOR WAS INSERTED INTO THE DEVICE. THE INSERTION REQUIRED NO UNDUE EFFORT, AND NO RECENTERING OF THE MIDDLE VALVE WAS NEEDED. A PRESSURE TEST WAS PERFORMED AND THE DEVICE SHOWED SIGNS OF LEAKING WHEN AN OBTURATOR WAS INSERTED INTO THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A BAD VALVE IN THE MIDDLE WHICH DID NOT RECENTER, MAKING IT HARD TO PUT A 12MM INSTRUMENT THROUGH DURING A LAPAROSCOPIC NISSEN PROCEDURE. THE PROCEDURE WAS FINISHED WITH THE DEVICE. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS NOT ALTERED. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177999 NA NLM STERILMED, INC. ETHCB12LT 1464058

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR