BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER TURBOVAC 90 IFS

    MDR report key: 10245044 · Received July 8, 2020

    Report

    Report Number
    3006524618-2020-00454
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    January 27, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE SUPER TURBOVAC 90 IFS WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS NOT ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2030176 FOUND NO NON-CONFORMANCE'S OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. VISUAL INSPECTION UNDER MAGNIFICATION SHOWS DRIED BLOOD/ TISSUE AND MINIMAL EROSION OF ELECTRODES. A BALL WIRE ELECTRODE IS MISSING. NO MANUFACTURING DISCREPANCIES OBSERVED. PRIOR TO THE FUNCTIONAL TESTING THE RESISTANCE OF THE R2 WAS MEASURED TO BE 1,625 OHMS. DURING FUNCTIONAL EVALUATION THE DEVICE WAS CONNECTED TO A COMPATIBLE QUANTUM2 CONTROLLER AND DID NOT WORK. AN ERROR E-7 OCCURRED. THE ERROR WAS BY-PASSED AND THE DEVICE PERFORMED AS INTENDED. THE SUCTION TUBE WAS TESTED AND PERFORMED AS SPECIFIED. THE COMPLAINT WAS NOT VERIFIED, AS THE DEVICE CREATES PLASMA AS INTENDED AFTER BYPASSING THE ERROR E-7; THERE ARE SEVERAL ROOT CAUSES THAT COULD HAVE CONTRIBUTED TO THE E-7 ERROR. THE RF CONTROLLER MAY HAVE BEEN TURNED OFF FOLLOWING CONNECTION OF THE WAND OR SOURCE POWER MAY HAVE BEEN INTERRUPTED PRIOR TO WAND ACTIVATION. OTHER FACTORS THAT COULD CONTRIBUTE TO AN E-7 ERROR INCLUDE DISCONNECTING THE WAND FROM THE CONTROLLER AFTER POWER HAS BEEN TURNED ON, PREVIOUS USE OR INCORRECT POWER CYCLING OF THE CONTROLLER. THERE WERE NO INDICATIONS 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, DURING A KNEE ARTHROSCOPY, THE SUPER TURBOVAC 90 IFS WAND STOPPED WORKING. ANOTHER WAND WAS OPENED AND WORKED VERY WELL. THIS TOOK APPROXIMATELY 5 MIN. THE PATIENT WAS NOT HARMED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE SHOWS DRIED BLOOD/ TISSUE AND MINIMAL EROSION OF ELECTRODES. A BALL WIRE ELECTRODE IS MISSING WHICH MAKES IT A REPORTABLE EVENT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712612 SUPER TURBOVAC 90 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. 2030176

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention