BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORATEC ELECTROTHERMAL SYSTEM

    MDR report key: 167605 · Received April 29, 1998

    Report

    Report Number
    2953127-1998-00002
    Event Type
    Other
    Date Received
    April 29, 1998
    Date of Event
    April 3, 1998
    Report Date
    April 29, 1998
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEALTH PROFESSIONAL STATED THAT AN ORATEC INTERVENTIONS RF GENERATOR AND TAC-S ELECTROTHERMAL PROBE WAS BEING UTILIZED FOR A SHOULDER ARTHROSCOPIC PROCEDURE. A CONMED CORPORATION DISPERSIVE ELECTRODE WAS ALSO USED IN THIS PROCEDURE. THE HEALTH PROFESSIONAL THEN STATED THAT THE PROCEDURE WAS GOING WELL UNTIL APPROXIMATELY 3/4 OF THE WAY THROUGH THE PROCEDURE WHEN IT WAS NOTICED THAT THE TEMPERATURE WOULD NOT GO ABOVE 40-42 DEGREES C. AT THIS POINT THE HEALTH PROFESSIONAL STATED THAT THEY REPLACED THE ELECTROTHERMAL PROBE AND THE CONNECTING CABLE AFTER WHICH THE SAME RESULTS WERE NOTICED. AT THIS POINT THE HEALTH PROFESSIONAL STATED THAT THEY DECIDED TO REPLACE THE PAD. WHEN THE PAD WAS REMOVED 3 BURNS WERE NOTICED ON THE PTS THIGH WITH CORRESPONDING AREAS ON THE DISPERSIVE ELECTRODE...THE DISTAL BURN WAS APPROXIMATELY 7.5X5CM WITH TWO OTHER SMALLER SATELLITE BURNS PROXIMAL, BOTH OF WHICH WERE APPROXIMATELY 1X2MM IN DIAMETER. A GENERAL SURGEON WAS BROUGHT IN AND TREATED THE AFFECTED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORATEC ELECTROTHERMAL SYSTEM RF GENERATOR & INDIFFERENT ELECTRODE GEI ORATEC INTERVENTIONS, INC. ORATEC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention