BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 2453792 · Received February 9, 2012

    Report

    Report Number
    9610614-2012-00001
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    January 17, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ERBE ELECTROMEDIZIN 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

    ARRANGEMENTS ARE BEING MADE TO HAVE THE TWO (2) APC/ESU SYSTEMS EVALUATED AT THE CUSTOMER'S FACILITY. A FOLLOW-UP REPORT WILL BE FILED WITH THE AGENCY UPON THE COMPLETION OF THE INVESTIGATION.

    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) WAS USED IN A PROCEDURE. THE SETTINGS WERE APC PULSED EFFECT 2 AT 20 WATTS WITH A 1.0 LITER PER MINUTE FLOWRATE. AFTER THE PROCEDURE A PERFORATION WAS DETECTED. SURGERY WAS PERFORMED TO ADDRESS THE PERFORATION. NOTE: THE INVOLVED EQUIPMENT WAS EVALUATED BY THE HOSPITAL'S CLINICAL ENGINEERING DEPARTMENT AND WAS FOUND TO BE FUNCTIONING AS INTENDED. HOWEVER, AT THIS TIME THE ACCOUNT COULD NOT BE CERTAIN WHICH ONE OF THEIR APC/ESU SYSTEMS WAS USED AT THE TIME OF THE INCIDENT. THE INVOLVED EQUIPMENT MAY ALSO INCLUDE APC (B)(4) AS WELL AS ESUS MODEL VIO 300 D, PART NUMBER 10140-000, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELECTROMEDIZIN GMBH APC 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention