BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 300

    MDR report key: 1741435 · Received June 25, 2010

    Report

    Report Number
    9610614-2010-00015
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    May 15, 2007
    Report Date
    June 25, 2010
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT PROBLEM WAS REPORTED AT THE TIME OF THE INCIDENT WHICH OCCURRED MORE THAN 3 YEARS AGO. NO EQUIPMENT ISSUES HAVE BEEN REPORTED SINCE THE TIME OF THE EVENT (NOTE: ERBE HAS NO RECORD OF ANY SERVICE ACTIVITIES INVOLVING THE APC OR ESU). AS A RESULT, AN EVALUATION OF THE EQUIPMENT AT THIS TIME IS NOT NECESSARY. 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 INVOLVED WITH THE INCIDENT. HOWEVER, IT APPEARS THAT UPON BIOPSYING TISSUE AND USING ARGON PLASMA TO ADDRESS THE BLEEDING IN A THIN WALLED AREA (I.E., THE RIGHT COLON), THE REMAINING WALL WAS NOT SUFFICIENT TO REMAIN INTACT WHICH RESULTED IN THE DELAYED PERFORATION. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. FURTHER IN-SERVICING WORK WAS PERFORMED WITH THE PHYSICIAN ON 05/24/2010. 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 300 WITH AN ELECTROSURGICAL GENERATOR MODEL ICC 200 E/A (PART NUMBER 10128-205 AND (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. THE SETTINGS WERE FORCED APC MODE AT 40 WATTS. ARGON PLASMA COAGULATION WAS USED TO TREAT ARTERIO VENOUS MALFORMATIONS (AVMS)/BLEEDING IN VARIOUS AREAS OF THE ASCENDING (RIGHT) COLON. ALSO, A BIOPSY WAS PERFORMED. THE PATIENT EXPERIENCED PAIN AND LATER A PERFORATION WAS DETECTED. SURGICAL INTERVENTION (I.E., RESECTIONING OF THE RIGHT COLON) WAS PERFORMED TO ADDRESS THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 300 ARGON PLASMA COAGULATOR GEI ERBE ELECTROMEDIZIN GMBH APC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention