BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3181864 · Received June 17, 2013

    Report

    Report Number
    2134070-2013-00126
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K123096
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON INVESTIGATION, THE DEVICE PASSED VISUAL INSPECTION AND ALL MECHANICAL AND ELECTRICAL TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS THE DEVICE PASSED ALL TESTING, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DEVICES WOULD NOT SEAL VESSELS DURING A TOTAL LAPAROSCOPIC VAGINAL HYSTERECTOMY. AN END TONE WAS HEARD INDICATING THAT THE VESSELS WERE SEALED. NO ERROR TONE WAS HEARD. THE PATIENT EXPERIENCED INCREASED BLEEDING DUE TO DELAYED PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO INJURY WAS REPORTED. THIS REPORT IS BEING FILED FOR THE FIRST DEVICE. SEE MFR REPORT NUMBER: 2134070-2013-00127 REGARDING THE OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273934 NA NUJ STERILMED, INC. COVLF1537 1658622

    Patients

    Seq Age Sex Outcome Treatment
    1