BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 7550

    MDR report key: 2220721 · Received January 7, 2011

    Report

    Report Number
    2220721
    Date Received
    January 7, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CONMED
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ARGON LASER WAS BEING USED ON THE PATIENT ON AND OFF DURING THE PROCEDURE. INADVERTENTLY, THE ALARM HAD BEEN SET TO LOW. WHEN THE DEVICE WAS NOT IN USE IT WAS SET ASIDE. THE SURGEON DID NOT REALIZE THAT SHE WAS DEPRESSING THE FOOT PEDAL AND OPERATING THE LASER WHICH BURNED THE PATIENT'S LEG. THERE IS NO HOLSTER FOR THIS DEVICE SO THE LASER EASILY BURNED THROUGH THE DRAPES AND THEN THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THIS WAS ESSENTIALLY OPERATOR ERROR, HOWEVER CLINICIANS FEEL THAT IF THERE WAS A HOLSTER THAT IT MAY HAVE STOPPED THE LASER FROM BURNING THE PATIENT. OR IF THERE WAS SOME WARNING THAT THE ALARM WAS LOWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 7550 ABC ELECTROSURGICAL GENERATOR GEI CONMED UNK *
    2 ABC ARGON BEAM COAGULATION PROBE LAPAROSCOPIC PROBE GEI CONMED CORP 5MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR