BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC-V GENERATOR ENGLISH

    MDR report key: 6476246 · Received April 10, 2017

    Report

    Report Number
    1226348-2017-10244
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    February 1, 2017
    Manufacturer
    SYNERGETICS INC. / CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    K050364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED. UPON COMPLETION OF THE INVESTIGATION A FOLLOWUP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE UNIT AS RECEIVED POWERED UP NORMALLY. THE PROBLEM WAS NOT DUPLICATED. THE UNIT HAS BEEN TESTED WARM AND COLD NUMEROUS TIMES OVER SEVERAL DAYS AND NO ISSUES WERE OBSERVED. POSSIBLE CAUSE IS AN INTERMITTENT COMPONENT ON THE CONTROLLER BOARD. THE CONTROLLER BOARD HAS BEEN REPLACED AS A PREVENTATIVE MEASURE. UNIT REQUIRES UPDATE ON LVPS CABLE ASSEMBLY WITH THE NEW CRIMPS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUTPUT POWER ADJUSTMENT FAILURE WAS OCCURRED WITH 80-1788 ON (B)(6) 2017. EVEN THOUGH THE DEVICE¿S DISPLAY SHOWED THE POWER WAS ADJUSTED TO THE DESIRED SETTING, THE ACTUAL OUTPUT POWER SEEMED NOT TO BE CHANGED. THE SAME EVENT WAS OCCURRED IN OCT 2016, AND THE DEVICE WAS CHECKED AT OUR DOMESTIC TECHNICAL CENTER. HOWEVER, AT THAT TIME, THE EVENT WAS NOT REPRODUCED AND IDENTIFIED. THE SURGEON IS NOW USING AN ALTERNATIVE BACKUP DEVICE WHICH AND COMMENTED THAT IT PERFORMS WELL. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259263 CMC-V GENERATOR ENGLISH ELECTROSURGICAL GENERATOR GEI SYNERGETICS INC. / CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1