BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXION MEDICAL

    MDR report key: 2479498 · Received February 28, 2012

    Report

    Report Number
    MW5024486
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 28, 2012
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC ASSISTED LAPAROSCOPIC PROCEDURE, THE CO2 GAS CONDITIONING DEVICE WAS OVER-SATURATED WITH NACL. THIS RESULTED IN VISUAL DISTURBANCES RESULTED IN THE FORM OF A "WHITE SNOW". NO HARM TO PT BUT IT DID DELAY THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXION MEDICAL LAPAROSCOPIC GAS CONDITIONING MACHINE FCX 074354001

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other