BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGYRF CONSOLE

    MDR report key: 10563409 · Received September 21, 2020

    Report

    Report Number
    1220246-2020-02193
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    September 10, 2020
    Report Date
    December 3, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    UDI-DI
    00888867142473
    PMA / PMN Number
    K161581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. THE FAILURE OF U28, RECOM DC/DC POWER SUPPLY, IS THE ROOT CAUSE OF THE FAILURE. THIS FAILED COMPONENT CAUSED THE VOLTAGE AND CURRENT SENSE CIRCUITS TO PRODUCE NO FEEDBACK SIGNALS TO THE SOFTWARE ALGORITHM. SINCE THE SOFTWARE DID NOT GET PROPER FEEDBACK, THE SOFTWARE PRODUCED AN ERROR AND DISPLAYED IT ON THE FRONT PANEL SCREEN. AT THE SAME TIME, THE SOFTWARE DISABLED ALL OUTPUT CHARACTERISTICS THUS ELIMINATING UNDESIRED OUTPUT CHARACTERISTICS TO BE DELIVERED TO THE PATIENT. RISK ANALYSIS WAS REVIEWED AND FOUND TO BE PROPER FOR THIS CONDITION.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE SEMS TECHNICAL SUPPORT SYSTEM THAT THE FACILITY HAD CALLED IN TO REPORT AN ISSUE WITH THE AR-9800, SYNERGYRF¿ CONSOLE SERIAL NUMBER: (B)(4). THE BOX WAS GIVING A RED POWER ISSUE MESSAGE. THE DEVICE WAS TROUBLE SHOT WITH TECHNICAL SUPPORT TEAM (TICKET 04737889) AND IT WAS DETERMINED THE DEVICE NEEDED TO COME IN FOR EVALUATION. IN THE PROCESS OF PERFORMING THE TECHNICAL SUPPORT IT WAS DISCOVERED THAT THE ISSUE OCCURRED DURING A CASE. THE PROCEDURE WAS CHANGED FROM A SHOULDER SCOPE TO AN OPEN PROCEDURE. AT THE TIME OF THE PROCEDURE THERE WAS ONLY THAT ONE CONSOLE AVAILABLE. THE PROCEDURE WAS A ROTATOR CUFF REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028652 SYNERGYRF CONSOLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC. SYNERGYRF¿ CONSOLE 10222322 00888867142473

    Patients

    Seq Age Sex Outcome Treatment
    1 Other