BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 1617334 · Received February 11, 2010

    Report

    Report Number
    9610614-2010-00004
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    January 5, 2010
    Report Date
    February 11, 2010
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND MOST SPECIFICALLY ALL OF THE OUTPUTS WERE/ARE WITHIN SPECIFICATIONS. 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 CONTRIBUTED TO THE EVENT. DURING THE EVAL, THE CHRONOLOGICAL LOG WAS ACCESSED AND THE ACTIVATION DATA AT THE TIME OF THE EVENT WAS REVIEWED. THE DATA REVEALED THAT THE ACTUAL SETTINGS USED FOR THE ERBE APC/ESU SYSTEM WERE APC PULSED, EFFECT 2 AT 40 WATTS WITH A TOTAL OF 88 ACTIVATIONS DURING THE PROCEDURE. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE INCIDENT AND NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. PER THE ACCOUNT, NO FURTHER IN-SERVICING WORK IS NECESSARY AT THE MEDICAL CENTER. 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 (B) (4)) WAS USED IN A ESOPHAGOGASTRODUODENOSCOPY (EGD) TO TREAT AN ARTERIOVENOUS MALFORMATION(S) [AVM(S)] IN THE DUODENUM. THE SETTINGS FOR THE ERBE APC/ESU SYSTEM WERE APC PULSED, EFFECT 2 AT 20 WATTS WITH A 1 LITER/MINUTE FLOW. IN RECOVERY, THE PT COMPLAINED OF PAIN AND BEGAN TO EXPERIENCE FACIAL EDEMA. THEREFORE, THE PT WAS ADMITTED TO THE ICU. THEN LATER THAT EVENING THE PT WAS TAKEN TO SURGERY WHERE A 2.5 CM PERFORATION WAS SURGICALLY REPAIRED. NOTE: THE EQUIPMENT WAS CHECKED BY THE HOSPITAL'S BIOMEDICAL DEPARTMENT AND NO PROBLEMS WERE FOUND.

    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 45 YR Hospitalization| L| R