BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3181866 · Received June 17, 2013

    Report

    Report Number
    2134070-2013-00124
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K121240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE OBTURATOR IN GOOD VISUAL CONDITION, BUT THE SEAL INSIDE THE SLEEVE WAS MISSING. UPON EVAL, THE DEVICE WAS PRESSURE TESTED AND WAS FOUND TO LEAK. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOT ASSISTED HYSTERECTOMY IT WAS FOUND THAT THERE WERE NO INTERNAL PIECES IN THE DEVICE AND THAT GAS LEAKED. THE ENTIRE INSIDES OF THE DEVICE WERE MISSING AND THERE WAS NOTHING TO STOP THE GAS FROM ESCAPING. THE DEVICE WAS REPLACED. THERE WAS A FOUR MINUTE DELAY WITH NO CHANGE IN PATIENT STATUS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274244 NA NLM STERILMED, INC. ETH2B5LT 1636760

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR