BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIF-PQ20

    MDR report key: 83527 · Received April 14, 1997

    Report

    Report Number
    2429304-1997-00012
    Event Type
    Injury
    Date Received
    April 14, 1997
    Date of Event
    March 13, 1997
    Report Date
    April 8, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A GASTROINTESTINAL FIBERSCOPE BURNED AND MELTED IN THE PT'S BRONCHUS DURING BROCHOSCOPY WHILE ATTEMPTING PARTIAL TUMOR REMOVAL IN A TERMINALLY ILL PT. PT, PREVIOUSLY SHEDULED TO REMAIN IN THE HOSP FOR EXTENDED CARE, REPORTEDLY SUFFERED SHORT TERM PROBLEMS DUE TO THE EVENT BUT ACCORDING TO THE HOSP RISK MANAGER, THE ADVERSE EVENT DID NOT ADD TO THE PREVIOULSY EXTENDED HOSP STAY. HOWEVER, THE PT WAS ADMITTED TO INTENSIVE CARE AND PLACED ON A VENTILATOR FOR FOUR DAYS AS A RESULT OF THE FIRE. PT, A STROKE VICTIM WITH AN INOPERABLE TUMOR HAS HAD PART OF THE TUMOR SUCCESSFULLY REMOVED DURING A SERIES OF PROCEDURES AND HAS HAD HIS AIRWAY RESTORED BY APPROX. 40%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIF-PQ20 GIF-PQ20 OES GASTROINTESTINAL FIBERSCOPE KOG THE OLYMPUS OPTICAL CO. LTD. GIF-PQ20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention