BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 5060801 · Received September 8, 2015

    Report

    Report Number
    3006524618-2015-00504
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    BWA
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED FOR EVALUATION AND THE COMPLAINT WAS VERIFIED. THE ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED WITH AN ELECTRICAL COMPONENT FAILURE WITHIN THE CONTROL BOARD WHICH COULD HAVE CAUSED NON-FUNCTIONALITY OF THE LEDS AND NO RECOGNITION OF CONNECTED WANDS. FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT INCLUDE: THERE MAY HAVE BEEN A POWER SURGE OR INTERRUPTION THAT COULD HAVE CAUSED INTERNAL COMPONENT FAILURE OF THE CONTROL BOARD; THERE MAY HAVE BEEN AN ISSUE WITH THE TURBINATE WAND THAT COULD HAVE CAUSED INTERNAL COMPONENT FAILURE OF THE CONTROL BOARD. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING A COBLATOR II CONTROLLER, THE UNIT STOPPED WORKING MID PROCEDURE WHEN THEY ATTEMPTED TO CONNECT A SECOND WAND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER, THIS DEFICIENCY CAUSED A 45 MINUTE SURGICAL DELAY. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591262 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT BWA ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1