BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS RF-S WHIRLWIND 90 DEGREES PROBE

    MDR report key: 2664604 · Received July 19, 2012

    Report

    Report Number
    3006524618-2012-00650
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    January 1, 2012
    Report Date
    June 25, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K090393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE U.S., DUE TO INTERNATIONAL PRIVACY LAWS, THE PT INFO WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING PRECAUTIONS: "AS WITH OTHER ELECTROSURGICAL UNITS, ELECTRODES AND CABLES CAN PROVIDE PATHS FOR HIGH FREQUENCY CURRENT. POSITION CABLES TO AVOID CONTACT WITH PT OR OTHER LEADS. OTHER ELECTRICAL EQUIPMENT MAY EXPERIENCE INTERFERENCE WHEN POSITIONED NEAR THE SYSTEM. HIGH FREQUENCY (HF) ELECTROSURGICAL EQUIPMENT MAY ADVERSELY AFFECT THE OPERATION OF OTHER ELECTRONIC EQUIPMENT. MONITORING ELECTRODES (E.G., ELECTROCARDIOGRAPHY (ECG)) SHOULD BE POSITIONED AS FAR AS POSSIBLE FROM THE SURGICAL ELECTRODES, WHEN HF SURGICAL EQUIPMENT AND PHYSIOLOGICAL MONITORING EQUIPMENT ARE USED SIMULTANEOUSLY, ON THE SAME PT. MONITORING NEEDLE ELECTRODES (E.G., ELECTROMYOGRAPHY (EMG)) ARE NOT RECOMMENDED." REFERENCE MFR REPORT: 30006524618-2012-00651.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC PROCEDURE, THE PHYSICIAN (B)(6), WAS USING A DYONICS RF-S WHIRLWIND 90 DEGREES PROBE. WHILE ABLATING, THE GENERATOR BEING USED, WOULD ALARM AND DISPLAY AN ERROR MESSAGE AND THE WAND WOULD STOP ABLATING. THE PROBE WAS CHANGED TO A WHIRLWIND 90 DEGREES OF A DIFFERENT LOT. AGAIN, WHILE ATTEMPTING TO ABLATE THE GENERATOR WOULD ALARM AND DISPLAY AN ERROR MESSAGE THEN STOP ABLATING. IN ADDITION, DURING THE PROCEDURE THE PT MONITORING SYSTEM WOULD FALSELY INDICATE THAT THE PT WAS IN TACHYCARDIA. THE PHYSICIAN NOTED A CORRELATION BETWEEN THE USE OF RF AND THE FALSE POSITIVE TACHYCARDIA READING. AS A RESULT, THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE USING A SHAVER BLADE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS RF-S WHIRLWIND 90 DEGREES PROBE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 0605420-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DYONICS RF GENERATOR