BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 1590948 · Received January 27, 2010

    Report

    Report Number
    MW5014559
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 27, 2010
    Manufacturer
    FUJINON INC.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FUJINON GASTROSCOPE #126 WAS SENT IN FOR REPAIRS DUE TO SCOPE WOULD NOT TAKE PICTURES, GASTROSCOPE #126 WAS RETURNED TO CENTER ON THURSDAY WITH FIRST USE MONDAY ON (B) (6) 2010. GASTROSCOPE #126 WORKED FINE UNTIL FIRST PICTURE WAS TAKEN THEN SUDDENLY STARTED TAKING PICTURES AT RANDOM WHILE PHYSICIAN WAS TRYING TO TAKE TISSUE BIOPSY., RANDOM PICTURE TAKING PREVENTED PHYSICIAN FROM VISUALIZING BIOPSY. AREA. TROUBLESHOOTING WAS DONE WHICH DID NOT IMPROVE SITUATION. GASTROSCOPE #126 REMOVED FROM GI TRACT WITH ANOTHER GASTROSCOPE #02 OBTAINED AND INSERTED WITHOUT PROBLEMS. NOTED GAGGING WITH INSERTION OF SECOND SCOPE DUE TO TIME LAPSE OF APPLICATION OF LOCAL ANESTHESIA TOPEX OF 14 MINUTES, PEEK TIME FOR TOPEX EFFECT ON TISSUE IS 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON GASTROSCOPE #126 FDS FUJINON INC. EG-250WR5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other