BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 803739 · Received January 5, 2007

    Report

    Report Number
    9610614-2006-00028
    Event Type
    Injury
    Date Received
    January 5, 2007
    Date of Event
    June 16, 2006
    Report Date
    January 4, 2007
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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 SPECIFICATIONS ON BOTH DEVICES (NOTE: UNRELATED TO THE REPORTED ISSUE, SOME ROUTINE SERVICE AND UPDATE WORK WAS 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 ATTRIBUTED TO THE EVENT. THE SETTINGS FOR THE APC/ESU SYSTEM WERE TYPICAL/COMMON FOR THE PROCEDURE. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE SITUATION. HOWEVER, THE PT'S MEDICAL CONDITION APPEARS TO HAVE BEEN A SIGNIFICANT FACTOR IN REGARDS TO THE INCIDENT. THAT IS, HAVING AN AVM IN THE RIGHT COLON, A VERY THIN WALLED AREA. AS A RESULT, UPON THE ARGON PLASMA COAGULATION TREATMENT FOR THE AVM, THE REMAINING WALL WAS NOT SUFFICIENT TO STAY INTACT WHICH RESULTED IN THE PERFORATION. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PLANNED AT THE MEDICAL CENTER. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. 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 SERIAL NUMBER 11250109) WAS INVOLVED IN A PATIENT INCIDENT. IN A COLONOSCOPY, ARGON PLASMA COAGULATION WAS USED TO TREAT AN ARTERIO VENOUS MALFORMATION (AVM) IN THE RIGHT COLON. THE EQUIPMENT SETTINGS WERE PULSED APC MODE, EFFECT 2 AT 20 WATTS. AFTER THE PROCEDURE, A PERFORATION WAS DETECTED AND SURGERY WAS PERFORMED TO ADDRESS THE SITUATION.

    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 71 YR Required Intervention