BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB030, VOYANT FINE FUSION, 6/BX

    MDR report key: 5777466 · Received July 7, 2016

    Report

    Report Number
    2027111-2016-00514
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    AMR
    Product Code
    GEI
    UDI-DI
    00607915127428
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT HAND PIECE WAS RETURNED FOR EVALUATION. DURING INSPECTION, ENGINEERING FOUND THAT THE GAP BETWEEN THE JAWS WAS INSUFFICIENT. THIS CONDITION CAN PREVENT THE ELECTRICAL CIRCUIT FROM BEING COMPLETED, WHICH WILL CAUSE THE DEVICE TO ALARM WHEN ACTIVATED. THIS CONDITION CAN ALSO INCREASE THE LIKELIHOOD OF TISSUE ADHERENCE TO THE DEVICE JAWS. ANALYSIS OF THE DEVICE KEY ACTIVATION LOGS CONFIRMED THE EVENT EXPERIENCE. DURING FUNCTIONAL TESTING, ENGINEERING OBSERVED TISSUE ADHERENCE TO THE DEVICE JAWS AND ALARMS WHEN THE DEVICE WAS ACTIVATED ON TISSUE. ENGINEERING WAS UNABLE TO REPLICATE THE INSUFFICIENT SEAL OBSERVED DURING THE REPORTED EVENT SINCE SEALED TISSUE SAMPLES WERE NOTED TO WITHSTAND ACCEPTABLE BURST PRESSURE VALUES. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS CONTINUOUS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THESE TYPES OF EVENTS TO OCCUR. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY TO ENSURE THE PERFORMANCE AND SAFETY OF THE PRODUCTS. ADDITIONAL INFORMATION REQUESTED AND RECEIVED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    THYROIDECTOMY- "I WAS PRESENT DURING THE SURGERY. AT THE BEGINNING, THE DEVICE WAS RECOGNISED BUT IT DOESN'T WORK (EACH ACTIVATION = ALARMS). I UNPLUGGED AND PLUGGED ONE MORE TIME => DEVICE RECOGNISED. AFTER THIS, EACH FUSION CYCLE WAS DEFECTIVE (TISSUES FLUTED TO THE DEVICE AND FUSION DOESN'T WORK WALL => BLEEDING) WE HAVE CHANGED THE DEVICE AND ALL WAS OK. THE SURGERY COULD CONTINUE AS USUAL. (SAME LOT NUMBER)." PATIENT STATUS - OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428754 EB030, VOYANT FINE FUSION, 6/BX GEI GEI AMR EB030 1267225 00607915127428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other