BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBON DIOXIDE INSUFFLATOR

    MDR report key: 101498 · Received June 26, 1997

    Report

    Report Number
    101498
    Event Type
    Injury
    Date Received
    June 26, 1997
    Date of Event
    May 19, 1997
    Report Date
    May 28, 1997
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUME.
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TO UNDERGO A DIAGNOSTIC POSSIBLE THERAPEUTIC, LAPAROSCOPY. AFTER INSERTION OF THE VERRES NEEDLE AND INJECTION OF 10CC OF NORMAL SALINE WITH NO RETURN, INSUFFLATION WAS BEGUN. INITIAL PRESSURES WERE HIGHER THAN ANTICIPATED, HOWEVER, NOT IN THE RED ZONE. THE VERESS NEEDLE WAS REMOVED AND REINSERTED, HOWEVER WITH REINSUFFLATION, SIMILAR PRESSURES WERE OBTAINED. SHORTLY THEREAFTER THE PT'S OXYGEN SATURATION DROPPED TO 70. THE PT WENT INTO VENTRICULAR FIBRILLATION AND CARDIAC ARREST. THE PT WAS SUBSEQUENTLY CONVERTED TO A SINUS RHYTHM WITH CARDIOVERSION AND REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON DIOXIDE INSUFFLATOR CARBON DIOXIDE INSUFFLATOR FCX RICHARD WOLF MEDICAL INSTRUME. 2026.60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L