BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 IFS

    MDR report key: 6696261 · Received July 9, 2017

    Report

    Report Number
    3006524618-2017-00168
    Event Type
    Malfunction
    Date Received
    July 9, 2017
    Date of Event
    June 19, 2017
    Report Date
    September 14, 2017
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL EVALUATION UNDER MAGNIFICATION SHOWS MINIMAL ELECTRODE WEAR WITH A SIGNIFICANT AMOUNT OF DISCOLORATION PRESENT ON THE SCREEN AND ON THE CAP. THERE IS DAMAGE TO THE BLACK SHRINK TUBE WHICH IS MOST LIKELY DUE TO PLASMA ETCHING. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED DEVICE. THE WAND WAS CONNECTED TO A COMPATIBLE CONTROLLER AND ACTIVATED IN SALINE SOLUTION AT THE DEFAULT AND MAX SETTINGS ON THE CONTROLLER AND PERFORMED AS INTENDED. UPON CONNECTION, THE TEMPERATURE THRESHOLD OF THE CONTROLLER DEFAULTED TO 45 DEGREES. DURING TESTING OF THE RETURNED WAND, THE TEMPERATURE DID NOT RISE ABOVE 30 DEGREES AND DID NOT CAUSE THE CONTROLLER TO ALARM. THE SUCTION LINE WAS TESTED AND PERFORMED AS INTENDED. THE COMPLAINT COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE AS THE TEMPERATURE WARNING ALARM WAS NOT EXHIBITED DURING FUNCTIONAL EVALUATION AND THE DEVICE FUNCTIONALLY PERFORMED AS INTENDED. IT IS POSSIBLE THAT THERE WAS NOT SUFFICIENT SUCTION PRESSURE IN ORDER TO ENSURE ADEQUATE FLOW AND CIRCULATION OF SALINE TO PREVENT UNNECESSARY HEATING WHICH COULD HAVE CAUSED THE TEMPERATURE TO ELEVATE AND TRIGGER THE CONTROLLER TO ALARM AND ALSO RESULT IN TISSUE DAMAGE OR THERMAL INJURY. LIKEWISE, THE USER MAY NOT HAVE SET THE CONTROLLER TEMPERATURE THRESHOLD TO THE DESIRED VALUE. THE INSTRUCTION FOR USE (¿IFU¿) OUTLINES WARNINGS AND PRECAUTIONARY MEASURES TO ADHERE TO DURING ACTIVATION OF THE DEVICE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE ISSUE WITH A PREVIOUSLY USED WAND (REF C-0150137/LOT 1170175) OF THE SAME TYPE, THE SURGEON OPTED TO DISCONTINUE USE OF THIS DEVICE UPON NOTICING BLACKENING ON THE BACK OF THE WAND TIP. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE DEVICE (STRYKER SHAVER). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476723 AMBIENT SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 1182599

    Patients

    Seq Age Sex Outcome Treatment
    1