BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 394403 · Received May 3, 2002

    Report

    Report Number
    MW4003280
    Event Type
    Death
    Date Received
    May 3, 2002
    Date of Event
    August 29, 2000
    Report Date
    May 3, 2002
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 7/26/02: PER THE DISCUSSION OF AN OLYMPUS REP, WITH REP FROM 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 THE DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    PT DIED AFTER UNDERGOING A BRONCHOSCOPE PROCEDURE WHILE AN IN-PATIENT AT THE HOSP. THERE WERE NO COMPLICATIONS FROM THE BRONCHOSCOPY; HOWEVER LATER THAT DAY PT WENT INTO SEPTIC SHOCK, REQUIRING MECHANICAL VENTILATION AND DIED TWO DAYS LATER. HOSP STATES THAT THE BRONCHOSCOPES USED DURING PT'S ADMISSION WERE MODELS BF-20 AND BF-P20, WHICH IS NOT AFFECTED BY THE RECENT RECALL BY OLYMPUS AMERICA. RPTR POINTS OUT THAT THE BF-20 WAS IMPLICATED IN THE TRANSMISSION OF INFECTION IN NEW YORK AS REPORTED BY THE NEW YORK STATE DEPT OF HEALTH IN 1996 AND 1998. HOSP RISK MGR STATED THAT THE BRONCHOSCOPE THAT WAS USED ON THE PT WAS NOT ONE THAT WAS INVOLVED IN THE RECALL NOR DID THEIR FINDINGS CONCLUDE THE PT'S DEATH WAS RELATED TO THE USE OF THE BRONCHOSCOPE. THEREFORE, A MEDWATCH FORM WAS NOT SUBMITTED TO FDA, NOR WAS THERE A REPORT MADE TO THE MFR.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 7/26/02: PER THE DISCUSSION OF AN OLYMPUS REP WITH REP FROM THE REPORTING SYSTEMS MONITORING BRANCH OF THE FDA, THE COMPLAINT WILL NOT BE SUBMITTED AS AN MDR. DUE TO THE SIGINIFICANT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BRONCHOSCOPE EOQ OLYMPUS AMERICA INC. BF-20 NA
    2 * BRONCHOSCOPE EOQ OLYMPUS AMERICA INC. BF-P20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death