BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS CONTROLLER

    MDR report key: 903881 · Received August 28, 2007

    Report

    Report Number
    2951580-2007-00051
    Event Type
    Injury
    Date Received
    August 28, 2007
    Date of Event
    June 29, 2007
    Report Date
    August 23, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K040338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN TURBOVAC 90 WAND AND ATLAS CONTROLLER THAT WERE USED IN THE SHOULDER ARTHROSCOPY PROCEDURE WERE RETURNED FOR EVALUATION. SEE MEDWATCH 2951580-2007-00040 SUBMITTED IN 2007, FOR A SUMMARY OF TESTING PERFORMED FOR WAND RETURNED FOR INVESTIGATION. A SUMMARY OF THE TESTING IS PROVIDED IN THIS MEDWATCH REPORT 2951580-2007-00051. 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 INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING A ATLAS CONTROLLER WAS REPORTED TO ARTHROCARE CORPORATION. FOLLOWING A SUBACROMIAL DECOMPRESSION PROCEDURE, IT WAS REPORTED THE PATIENT SUSTAINED A BURN RESULTING IN A BLISTER, 2 CM X 7 CM IN SIZE, ADJACENT TO THE PORTAL. THE PATIENT REPORTED PAIN, BUT WAS NOT PRESCRIBED MEDICATION. THE BLISTER WAS ALLOWED TO HEAL ON ITS OWN AND NO TREATMENT IS PLANNED. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other