BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 1287509 · Received January 9, 2009

    Report

    Report Number
    9610614-2008-00023
    Event Type
    Injury
    Date Received
    January 9, 2009
    Date of Event
    December 10, 2008
    Report Date
    January 9, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE APC AND ESU DEVICES WERE EVALUATED BY THE HOSP'S BIOMEDICAL DEPT AND FOUND TO BE WORKING PROPERLY. THE APC/ESU SYSTEM'S DEFAULT PROGRAMS/SETTINGS WERE RE-INSTALLED. THEN THE SYSTEM WAS PLACED BACK INTO SVC (NOTE: NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT; THEREFORE, THE UNITS WERE NOT RETURNED TO ERBE FOR EVAL.). A DEVICE HISTORY RECORD (DHR) REVIEW AT ERBE DID NOT REVEAL ANY ANOMALIES WITH THE APC/ESU SYSTEM. IT APPEARS THAT UPON TREATING THE AVMS, THE REMAINING WALL WAS NOT SUFFICIENT TO REMAIN INTACT. NONETHELESS, 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, ADD'L IN-SVC WORK WILL BE OFFERED TO THE MEDICAL STAFF AT THE HOSP. 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 UNIT (ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER 10140-000) WAS USED IN A PROCEDURE TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE STOMACH. THE SETTINGS FOR THE ERBE APC/ESU SYSTEM WERE APC PULSED, EFFECT 1 AT 35 WATTS. POST OPERATIVELY, A PERFORATION WAS DISCOVERED. SURGERY WAS THEN PERFORMED TO ADDRESS THE PERFORATION.

    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 83 YR Required Intervention