BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS CONTROLLER

    MDR report key: 1549435 · Received November 30, 2009

    Report

    Report Number
    2951580-2009-00124
    Event Type
    Injury
    Date Received
    November 30, 2009
    Date of Event
    April 2, 2009
    Report Date
    November 30, 2009
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K040338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARTHROCARE ATLAS CONTROLLER WAS RETURNED FOR INVESTIGATION WHICH MAY HAVE BEEN USED WITH THE WANDS REPORTED IN THE FOLLOWING MDRS: MDR 2951580-2009-00079, MDR 2951580-2009-00089, MDR 2951580-2009-00090, MDR 2951580-2009-00091, MDR 2951580-2009-00101. THE ATLAS CONTROLLER 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 ABLATION OPEN CIRCUIT OUTPUT VOLTAGES, CHECK OF THE COAGULATION OPEN CIRCUIT OUTPUT VOLTAGES, CHECKS OF THE MAXIMUM LOADED VOLTAGE, CHECKS OF THE LIMITING MODES AT SET POINT 9, 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. THE CONTROLLER MET ALL DEVICE TEST SPECIFICATIONS. BASED ON THE TESTING PERFORMED AND THE INFORMATION PROVIDED BY THE USER FACILITY, NO CONCLUSION CAN BE MADE. ALL OPERATING ROOM PERSONNEL WILL BE RE-TRAINED ON THE USE OF THESE ARTHROCARE DEVICES IN 2009. THE SURGEONS AND OR STAFF HAVE ALREADY BEEN ADVISED ON THE USE OF THE EQUIPMENT.

    Description of Event or Problem · 1

    FOLLOWING A KNEE ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE PATIENT HAD SUSTAINED A POST-SURGICAL BURN TO PATIENT'S LOWER LEG BELOW THE SURGICAL SITE. IT WAS REPORTED THE WAND SUCTION LINE WAS NOT ATTACHED TO HOSPITAL VACUUM EQUIPMENT SET AT 200 TO 400 MMHG AS PRESCRIBED BY THE INSTRUCTION FOR USE. THE SUCTION LINE HAD BEEN ATTACHED TO A PERISTALTIC PUMP FOR CONTROL OF SUCTION DURING THE PROCEDURE. THE PHYSICIAN STATED THAT HE BELIEVES THE BURNS WERE POSSIBLY CAUSED BY AN ELECTRIC ARC OF THE WAND CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS CONTROLLER ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other