BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 384199 · Received March 22, 2002

    Report

    Report Number
    384199
    Event Type
    Other
    Date Received
    March 22, 2002
    Date of Event
    March 4, 2002
    Report Date
    March 21, 2002
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COLONOSCOPY IN 2002. EIGHT DAYS LATER, FACILITY WAS NOTIFIED BY PT'S PHYSICIAN THAT PT DEVELOPED A BOWEL PERFORATION AND EXPIRED AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS PCF - 140L PEDIATRIC COLONOSCOPE FDF OLYMPUS AMERICA INC. PCF - 140L *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other