BEUDAMED
    FDA Adverse Event Death Summary report: N

    BF-P200 BRONCHO

    MDR report key: 98966 · Received June 17, 1997

    Report

    Report Number
    2429304-1997-00018
    Event Type
    Death
    Date Received
    June 17, 1997
    Date of Event
    May 27, 1997
    Report Date
    May 27, 1997
    Manufacturer
    OLYMPUS OPTICAL CO. LTD., SHINJUKU SAN-EI BLDG
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN OLYMPUS SALES REP REPORTED THE EVENT DURING HIS VISIT TO THE FACILITY. A BRONCHOSCOPY WAS PERFROMED ON THE PT, WHO WAS PRESENTED WITH BREATHING DIFFICULTIES AND WHEEZING. IT WAS REPORTED THAT THE PT HAD SUFFERED FROM DIFFICULT BREATHING OVER THE WEEKEND AND COMPLAINED OF COPIOUS MUCUS SECRETIONS. NO PRIOR MEDICAL HISTORICAL INFO IS AVAILABLE, NOR ANY REPORTED LABORATORY OR TEST DATA ASSOCIATED WITH THE PT. DURING THE BRONCHOSCOPY, THE PHYSICIAN ATTEMPTED TO ASPIRATE THE MUCUS SECRETIONS, AND ENCOUNTERED DIFFICULTY IN ASPIRATION DUE TO THE VISCOSITY AND COPIUS VOLUME OF MUCUS. THE PHYSICIAN WAS REQUIRED TO REMOVE THE BRONCHOSCOPE APPROX THREE (3) TIMES TO UNPLUG MUCUS FROM THE SUCTION CHANNEL OF THE SCOPE. DURING THIS TIME, THE PT'S CONDITION DETERIORATED AND THE PHYSICIAN IMMEDIATELY INTUBATED THE PT, ADMINISTERED OXYGEN AND INITIATED CARDIOPULMONARY RESUSCITATION (CPR). PHYSICIAN INSERTED A SECOND SCOPE TO EVALUATE PROPER POSITIONING OF THE INTUBATION TUBE. THE PT SUCCUMBED A SHORT TIME LATER. AN AUTOPSY WAS CONDUCTED TO DETERMINE CAUSE OF DEATH-NO RESULTS ARE CURRENTLY AVAILABLE TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BF-P200 BRONCHO BF-P200 VIDEO BRONCHOSCOPE EOQ OLYMPUS OPTICAL CO. LTD., SHINJUKU SAN-EI BLDG BF-P200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death