BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ELECTROSURGICAL ELECTRODE

    MDR report key: 6088216 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00039
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 29, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    GEI
    UDI-DI
    10888277379855
    PMA / PMN Number
    K012669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION. UPON RECEIPT, MEDLINE RENEWAL CONFIRMED THE DEVICE HAD BEEN REPROCESSED. FURTHER EVALUATION FOUND THAT THE DEVICE PASSED ALL FUNCTIONAL AND ELECTRICAL TESTS; THEREFORE THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. OUR INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, AND WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. THE SPECIFIC CAUSE OF THE FAILURE COULD NOT BE DETERMINED. ALTHOUGH NO PATIENT HARM WAS REPORTED, A DELAY IN THE PROCEDURE WAS REPORTED DUE TO OBTAINING A NEW DEVICE; THEREFORE MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING A REPROCESSED DEPUY MITEK VAPR SIDE EFFECT ELECTRODE, W/INTEGRATED HAND PIECE, MODEL 227301, WAS NOT RECOGNIZED BY THE GENERATOR WHEN IT WAS PLUGGED IN DURING A SURGICAL PROCEDURE. THEREFORE THE DEVICE COULD NOT BE USED. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN ANY PATIENT HARM. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738383 MEDLINE RENEWAL REPROCESSED ELECTROSURGICAL ELECTRODE ELECTROSURGICAL ELECTRODE GEI MEDLINE RENEWAL 227301 316408 10888277379855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention