BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 3760680 · Received April 11, 2014

    Report

    Report Number
    9610614-2014-00003
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE CUSTOMER'S FACILITY. THE UNITS WERE THOROUGHLY INSPECTED/TESTED. SPECIFICALLY, 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 FOR THE APC. ALL EQUIPMENT OUTPUTS WERE FOUND TO BE WITHIN SPECIFICATION. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO EQUIPMENT RELATED ISSUE WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, IT APPEARS THAT UPON THE INTERVENTION, THE REMAINING WALL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PLANNED WITH THE INVOLVED MEDICAL STAFF. ERBE USA, INC. IS NOT CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL SPC 2 WITH AN ELECTROSURGICAL GENERATOR MODEL VIO 300 D (PART NUMBER 10140-000, SERIAL NUMBER (B)(4)) WAS USED IN THE CECUM OF A PT (NOTE: THE PT HAD OTHER COMPLICATED HEALTH ISSUES). THE SETTINGS WERE APC PULSED, EFFECT 2 AT 20 WATTS (FLOWRATE: 0.5 LITERS/MINUTE). A PERFORATION WAS DETACHED APPROXIMATELY 10 HOURS AFTER THE PROCEDURE (IE., THERE WAS FREE AIR IN ABDOMEN). THE PT DEVELOPED SEPSIS AND DIED. NOTE: ALTHOUGH NOT PREVIOUSLY REPORTED OR CONFIRMED, IT WAS CONVEYED THAT THE PHYSICIAN HAD TWO (2) OTHER PERFORATION EVENTS SEVERAL MONTHS AGO WHILE USING ARGON PLASMA COAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220580 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death