BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSUFLOW LAPAROSCOPIC GAS CONDITIONING DEVICE

    MDR report key: 2213254 · Received August 10, 2011

    Report

    Report Number
    MW5021720
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 10, 2011
    Manufacturer
    LEXION MEDICAL
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEXION MEDICAL INSUFLOW GAS CONDITIONING DEVICE OVERHEATED AND BLEW SMOKE INTO THE PT'S ABDOMEN DURING A ROBOTIC HYSTERECTOMY SURGERY. AFTER THE SOURCE OF THE SMOKE WAS DISCOVERED, THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. NO APPARENT OR IMMEDIATE HARM TO THE PT WAS FOUND. LEXION WAS NOTIFIED VIA THE COMPANY REP. THE DEVICE ALONG WITH THE CONTROL BOX AND THE AFFECTED LOT WERE RETURNED TO LEXION FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFLOW LAPAROSCOPIC GAS CONDITIONING DEVICE INSUFLOW HIF LEXION MEDICAL 074139001

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability