BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 8163810 · Received December 14, 2018

    Report

    Report Number
    9610614-2018-00019
    Event Type
    Death
    Date Received
    December 14, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 14, 2018
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED (NOTE: THE APC PROBE WAS NOT MADE AVAILABLE FOR AN EXAMINATION.). A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALSO, THE GAS FLOW RATES WERE MEASURED AND FOUND TO BE WITHIN THEIR ACCEPTABLE RANGES FOR THE APC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON BOTH DEVICES. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. BASED UPON THE INFORMATION PROVIDED, IT APPEARS THAT THE OXYGEN LEVEL WAS AT SUCH A CONCENTRATION THAT COMBUSTION OCCURRED DURING COAGULATION. ALTHOUGH VERY RARE THE COMPLICATION CAN OCCUR. THEREFORE, ERBE PROVIDES A WARNING IN THE USER MANUAL INVOLVING NOT USING OR REMOVING COMBUSTIBLE GASES (LIKE OXYGEN) IN HEAD OR THORAX PROCEDURES PRIOR TO ELECTROSURGERY (I.E., ACTIVATION). NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 200 D, PART NUMBER 10140-000, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. A BRONCHOSCOPY WAS PERFORMED AND OXYGEN WAS ADMINISTERED DURING THE PROCEDURE. NO INFORMATION WAS PROVIDED REGARDING THE REASON FOR THE BRONCHOSCOPY OR THE SETTINGS USED. AN APC PROBE WAS USED WITH APC/ESU SYSTEM. DURING ARGON PLASMA COAGULATION, DEFLAGRATION OCCURRED. TWO (2) DAYS AFTER THE PROCEDURE, THE PATIENT DIED. NO FURTHER INFORMATION WAS PROVIDED AS TO WHETHER THE DEATH WAS A RESULT OF THE COMBUSTION AND/OR THE PATIENT'S ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005302 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death