BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRONCHOSCOPE

    MDR report key: 380546 · Received March 6, 2002

    Report

    Report Number
    MW1024282
    Event Type
    Death
    Date Received
    March 6, 2002
    Date of Event
    February 10, 2002
    Report Date
    March 6, 2002
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 08/16/02: PER OLYMPUS' CONVERSATION WITH THE REPORTING SYSTEMS MONITORING BRANCH OF THE FDA, THE COMPLAINT WILL NOT BE SUBMITTED AS AN MDR. DUE TO THE SIGNIFICANT AMOUNT OF UNDISCLOSED, I.E., REDACTED INFO IN THE COMPLAINT, OLYMPUS IS UNABLE TO DETERMINE IF THE INFO REASONABLY SUGGESTS THAT THE OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AT THE HOSP THE FOLLOWING EVENTS HAPPENED. PT WAS ALREADY ADMITTED TO THE HOSP, THEY DECIDED SINCE PT HAD FLUID IN CHEST CAVITY TO MOVE PT TO ICU. PT WAS GIVEN A CHEST TUBE TO DRAIN THE FLUID AND A BRONCHOSCOPE AT THE SAME TIME. THEY KEPT PT AS A PARALYTIC PT AND, FOR A COUPLE OF DAYS THERE WERE NO CHANGES. FOUR DAYS LATER THE HOSP CALLED AND SAID THEY DIDN'T EXPECT PT TO LIVE THROUGH THE NIGHT. PT PROGRESSIVELY GOT WORSE AND DIED AT 10:30 AM FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHOSCOPE BRONCHOSCOPE EOQ OLYMPUS AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death