BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUN MEDICAL SMOKE EVACUATOR

    MDR report key: 33641 · Received June 4, 1996

    Report

    Report Number
    33641
    Event Type
    Injury
    Date Received
    June 4, 1996
    Date of Event
    June 3, 1996
    Report Date
    June 4, 1996
    Manufacturer
    SUN MEDICAL, INC.
    Product Code
    FCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAP CHOLECYSTECTOMY, VENTILATING PRESSURES RAPIDLY INCREASED TO 60-70 WHEN SMOKE EVACUATOR WAS TURNED ON. ABDOMINAL PRESSURE WENT INTO 20'S. WHEN EVACUATOR TURNED OFF, PRESSURES RETURNED TO NORMAL. EVACUATOR TURNED ON X2, WITH SAME RESULTS. EVACUATOR NOT USED FOR REMAINDER OF CASE. "TANDEM" CAP ON SMOKE EVACUATOR FOUND UNCAPPED AT THE END OF THE CASE. NO ALARM ON MEDICAL DEVICE. PNEUMOTHORAX WAS IDENTIFIED ON CHEST X-RAY, 14G CATH PLACED TO ASPIRATE PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUN MEDICAL SMOKE EVACUATOR SMOKE EVACUATOR FCZ SUN MEDICAL, INC. SE-100

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R