BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 2200770 · Received July 28, 2011

    Report

    Report Number
    9610614-2011-00008
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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 EVENTS (NOTE: UNRELATED TO THE REPORTED INCIDENTS, SOME SERVICE WORK WAS PERFORMED ON THE UNITS). THE COMPLICATION IS TYPICAL FOR THE PROCEDURE. FURTHERMORE, BASED UPON PAST REPORTS, IT APPEARS THAT BOTH OF THE PT'S CONDITIONS WERE A SIGNIFICANT FACTOR IN THE EVENT. THAT IS, UPON ARGON PLASMA TREATMENT IN A THIN WALLED AREA (I.E. THE CECUM), THE REMAINING WALL WAS NOT SUFFICIENT TO REMAIN INTACT. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENTS. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO ADDRESS THE ISSUES, ADD'L IN-SERVICE WORK WAS PERFORMED WITH THE INVOLVED MEDICAL STAFF AT THE HOSPITAL ON (B)(6) 2011. 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 (B)(4)) WAS USED IN COLONOSCOPIES. FOR BOTH PATIENTS, ARGON PLASMA COAGULATION WAS APPLIED IN THE CECUM TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS). THE SETTINGS FOR THE FIRST PROCEDURE ON (B)(6) 2011 WERE APC PULSED, EFFECT 2 AT 15 WATTS AND THE SECOND PROCEDURE ON (B)(6) 2011 SETTINGS WERE APC PULSED, EFFECT 2, 30 - 35 WATTS. BOTH PATIENTS HAD PAIN WITH A PERFORATION. SURGERY WAS THEN PERFORMED TO ADDRESS THE PERFORATION FOR BOTH INDIVIDUALS AND THEY ARE BOTH IN GOOD CONDITION. THE STAFF NURSES BELIEVE THAT THE EQUIPMENT WAS USED CORRECTLY AND DID NOT CAUSE THE REPORTED COMPLICATION.

    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 NI Required Intervention