BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERESS PNEUMO NEEDLE

    MDR report key: 291190 · Received August 17, 2000

    Report

    Report Number
    291190
    Event Type
    Death
    Date Received
    August 17, 2000
    Date of Event
    July 14, 2000
    Report Date
    August 16, 2000
    Manufacturer
    IMAGYN MEDICAL TECHNOLOGIES
    Product Code
    FHO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LAPAROSCOPIC CHOLECYSTECTOMY. 150MM DISPOSABLE PNEUMO-NEEDLE WAS USED WITH A 120MM REUSABLE PNEUMO NEEDLE BODY, SHARP NEEDLE PROTRUDED INSTEAD OF BLUNT END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERESS PNEUMO NEEDLE VERESS PNEUMO NEEDLE FHO IMAGYN MEDICAL TECHNOLOGIES EXEL-DR PNEUMO NEEDLE UNK
    2 VERESS PNEUMO NEEDLE DETACH A TIP PNEUMO NEEDLE FHO MICRO SURGE INC DETACHA TIP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| R TROCHAR INSERTED IMMEDIATELY AFTER INSUFFLATION.| 7/14/2000.