BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 300

    MDR report key: 793707 · Received December 11, 2006

    Report

    Report Number
    9610614-2006-00024
    Event Type
    Injury
    Date Received
    December 11, 2006
    Date of Event
    November 8, 2006
    Report Date
    December 8, 2006
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT SENT THE APC/ESU SYSTEM TO AN INDEPENDENT TESTING HOUSE. THE CUSTOMER REPORTED TO US THAT NO PROBLEMS WERE FOUND WITH THE UNITS AND THE SYSTEM WAS PLACED BACK INTO SERVICE (NOTE: THE ACCOUNT DOES NOT SEE ANY REASON TO HAVE THE EQUIPMENT INSPECTED/TESTED FURTHER BY ERBE USA, INC.). NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. NO DETERMINATION AS TO THE CAUSE OF THIS SITUATION COULD BE MADE. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK AT THE MEDICAL CENTER FOR THEIR STAFF WILL BE PERFORMED IN THE FUTURE. 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

    THE MEDICAL FACILITY REPORTED THAT THE ERBE ARGON PLASMA COAGULATOR (APC) MODEL APC 300 WITH AN ELECTROSURGICAL UNIT (ESU) MODEL ICC 200 E/A (PART NUMBER 10128-205) [APC/ESU SYSTEM] WAS INVOLVED IN A PT INCIDENT. THE SETTINGS WERE APC FORCED AT 60 WATTS WITH A FLOW RATE OF 0.8 LITERS/MINUTE. ARGON PLASMA COAGULATION WAS USED TO TREAT A PT IN AN UNSPECIFIED PROCEDURE. HOWEVER, A PERFORATION OCCURRED AND SURGERY WAS PERFORMED ON THE PT TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention