BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2982733 · Received February 25, 2013

    Report

    Report Number
    2134070-2013-00037
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K120040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE CORD SEVERED APPROXIMATELY 2 INCHES FROM THE HANDLE. THE JAWS OF THE DEVICE APPEARED PROPERLY ALIGNED, AND FULLY OPENED AND CLOSED AS INTENDED WHEN THE HANDLE WAS ACTUATED. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE SEVERED CORD. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS THE DEVICE JAWS OPERATED AS DESIGNED DURING TESTING, NO CONCLUSION COULD BE DRAWN AS TO WHAT MAY HAVE CAUSED THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL HYSTERECTOMY THE DEVICE WORKED WELL FOR THE FIRST SEAL AND DIVIDE BUT THE JAWS WOULD NOT OPEN AFTER THAT. IT WAS NOT REPORTED WHETHER THE DEVICE WAS STUCK ON TISSUE WHEN IT WOULD NOT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN SURGERY, BUT NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79165 NA NUJ STERILMED, INC. COVLF4200

    Patients

    Seq Age Sex Outcome Treatment
    1