BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 1975493 · Received January 26, 2011

    Report

    Report Number
    9610614-2011-00001
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. 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 SPECS ON BOTH DEVICES AND MOST SPECIFICALLY ALL OF THE OUTPUTS WERE/ARE WITHIN SPECS (NOTE: UNRELATED TO THE REPORTED ISSUE, SOME ROUTINE UPGRADE WORK WAS ALSO PERFORMED ON THE EQUIPMENT). 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 CONTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS (E.G. THE AGE OF THE PT, DISEASE STATE, ETC.) INVOLVED WITH THE INCIDENT. HOWEVER IT APPEARS THAT UPON ARGON PLASMA TREATMENT OF THE MASS IN THE BOWEL, THE REMAINING WALL WAS NOT SUFFICIENT TO REMAIN INTACT WHICH RESULTED IN THE PERFORATION. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADD'L IN-SERVICE WORK IS BEING PLANNED ON (B)(4) 2011 WITH THE MEDICAL STAFF AT THE FACILITY. 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) MODEL APC 2 WITH AN ELECTROSURGICAL GENERATOR MODEL VIO 300 D (PART NUMBER 10140-000 AND (B)(4)) WAS USED IN A COLONOSCOPY TO TREAT A MASS IN THE BOWEL. THE SETTINGS FOR THE ERBE APC/ESU SYSTEM WERE APC PULSED, EFFECT 2 AT 20 WATTS. A PERFORATION OCCURRED AND SURGICAL INTERVENTION (I.E., A RIGHT HEMICOLECTOMY) WAS PERFORMED TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention