BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBLATOR II CONTROLLER

    MDR report key: 5051671 · Received September 2, 2015

    Report

    Report Number
    3006524618-2015-00505
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 12, 2015
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    BWA
    PMA / PMN Number
    K030108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER, FOOT CONTROL AND WAND RELATED TO THIS COMPLAINT EVENT WERE RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTION WAS DONE AND ALL DEVICES FUNCTIONED AS INTENDED. THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED IN ASSOCIATION WITH THE SUBJECT SYSTEM DUE TO THE CONTROLLER, FOOT CONTROL ASSEMBLY, AND WAND FUNCTIONING AS INTENDED WHEN TESTED. POTENTIAL FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: 1. INSUFFICIENT SALINE FLOW TO THE SURGICAL SITE DURING THE PROCEDURE. 2. SURGICAL TECHNIQUE OF THE USER. 3. AN ISSUE WITH ONE OF THE CONCOMITANT DEVICES. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICES DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TONSILLECTOMY PROCEDURE USING A COBLATOR II CONTROLLER WITH AN EVAC 70 XTRA HP WAND, IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A SMALL BURN ON THE TONGUE. NO FURTHER DETAILS WERE PROVIDED REGARDING THE SEVERITY OF THE BURN OR ANY TREATMENT ADMINISTERED, HOWEVER NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581639 COBLATOR II CONTROLLER OPERATOR CONSOLE, DIATHERMY UNIT BWA ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other