BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMC-V GENERATOR ENGLISH

    MDR report key: 5247349 · Received November 24, 2015

    Report

    Report Number
    1226348-2015-10706
    Event Type
    Injury
    Date Received
    November 24, 2015
    Manufacturer
    SYNERGETICS INC. / CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    PK050364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT WE COULD NOT DUPLICATE COMPLAINT. UNIT WAS TESTED NUMEROUS TIMES OVER SEVERAL DAYS. UNIT WAS TESTED WARM AND COLD. NO ISSUES WERE OBSERVED. AFTER CONSULTING WITH THE ENGINEERING DEPARTMENT, IT WAS DECIDED THAT THE HIGH VOLTAGE POWER SUPPLY AND CONTROLLER BOARD NEEDS TO BE REPLACED AS A PREVENTATIVE MEASURE. UNIT NEEDS TO BE UPDATED WITH THE NEW LVPS CABLE ASSEMBLY. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING BOTH IN SERVICES THAT I HAVE ON A NEW CMCV, AN ERROR MESSAGE OF TOO MUCH VOLTAGE CAME UP. IT IS SET TO 110V. THE UNIT PLUGGED INTO A 110 V OUTLET YOU HAVE THE VOLTAGE SWITCH SET TO THE 110 V SETTING ON THE BACK OF THE GENERATOR THE UNIT DISPLAYS A HIGH VOLTAGE OUTPUT ERROR. THE ERROR CAME UP WHEN I HAD EMPTY TUBING IN, IRRIGATION ON AND THEN I WAS SWITCHING BETWEEN MUTE, X1 OR ALL THE TIME. I SHUT IT OFF AND IT WENT AWAY. HOWEVER, IT HAPPENED AGAIN DURING THE AFTERNOON IN SERVICE. SOUNDS LIKE THERE IS AN ISSUE IN THE CONTROLLER BOARD, SINCE THE UNIT IS UNDER WARRANTY I WOULD RECOMMEND REACHING OUT TO THE COMPLAINT DEPARTMENT TO GET THE UNIT REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775680 CMC-V GENERATOR ENGLISH ELECTROSURGICAL GENERATOR GEI SYNERGETICS INC. / CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention