BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATLAS CONTROLLER

    MDR report key: 854680 · Received May 24, 2007

    Report

    Report Number
    2951580-2007-00023
    Event Type
    Other
    Date Received
    May 24, 2007
    Date of Event
    April 19, 2007
    Report Date
    May 21, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K040338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED AS A MALE. THE INITIAL REPORTER DOES NOT HAVE THE WEIGHT INFORMATION, THEREFORE, WEIGHT IS BEING PROVIDED AS AN APPROXIMATION BY MANUFACTURER. AN ELIMINATOR WAND AND ATLAS CONTROLLER THAT WERE USED IN THE RIGHT SHOULDER ARTHROSCOPY PROCEDURE WERE RETURNED FOR EVALUATION. SEE MEDWATCH 2951580-2007-00020 SUBMITTED ON 5/17/2007 FOR A SUMMARY OF TESTING PERFORMED FOR WAND RETURNED FOR INVESTIGATION. THE INVESTIGATION OF THE ATLAS CONTROLLER IS SUMMARIZED IN THIS MEDWATCH REPORT. THE ATLAS CONTROLLER RETURNED FOR THIS REPORT WAS TESTED ACCORDING TO ARTHROCARE'S TEST PROCEDURE WHICH INCLUDES CHECKS OF THE DEFAULT AND MAXIMUM SET POINTS AT SPECIFIC RESISTANCE VALUES, CHECKS OF THE OPEN CIRCUIT OUTPUT VOLTAGES, CHECK OF THE COAGULATION OPEN CIRCUIT OUTPUT VOLTAGE, CHECKS OF THE MAXIMUM LOADED VOLTAGE, CHECKS OF THE LIMITING MODES AT THE MAXIMUM SET POINT, AND A PERFORMANCE TEST (SALINE TEST) OF THE DEVICE IN USE WITH A WAND TO VERIFY COBLATION MODE. THE DEVICE WAS FOUND TO MEET ALL PERFORMANCE AND ELECTRICAL TESTS. BASED ON THE TESTING PERFORMED AND THE INFORMATION PROVIDED BY THE USER FACILITY, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE SKIN INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING AN ATLAS CONTROLLER WAS REPORTED TO ARTHROCARE CORPORATION. FOLLOWING A RIGHT SHOULDER ARTHROSCOPY PROCEDURE, THE PATIENT WAS REPORTED TO HAVE SUSTAINED A SKIN INJURY MEASURING 2 X 1 CM IN SIZE (APPROXIMATELY THE SIZE OF A NICKEL) ON THE PATIENT'S SKIN NEAR THE INFERIOR SIDE OF THE PORTAL. THE SKIN INJURY WAS TREATED WITH MEDICAL OINTMENT. THE PHYSICIAN REPORTED THAT THIS SKIN INJURY WAS A DISCOLORATION OF THE SKIN AND DOES NOT CONSIDER IT A BURN. IT WAS REPORTED THE IRRIGATION SYSTEM WAS FLOWING THROUGHOUT THE PROCEDURE. THE PHYSICIAN REPORTED THE SHAFT OR HANDLE OF THE DEVICE MAY HAVE COME IN CONTACT WITH THE PATIENT SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS CONTROLLER ELECTROSURGICAL, CUTTING AND COAGULATION DEVICE GEI ARTHROCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other