BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 6479948 · Received April 11, 2017

    Report

    Report Number
    6479948
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    January 6, 2017
    Report Date
    March 10, 2017
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    GDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ESOPHAGOGASTRODUODENOSCOPY WITH DOUBLE BALLOON ENTEROSCOPY NN: FUJINON DOUBLE BALLOON SCOPE BROKE DURING THE PROCEDURE. WE CHANGED TO A SECOND SCOPE. THE BROKEN SCOPE WAS IMMEDIATELY SENT OUT FOR REPAIR PER OUR PROTOCOL. THE DOUBLE BALLOON ENTEROSCOPY PROCEDURE HAS A POTENTIAL FOR GASTRIC MUCOSAL INJURY BECAUSE OF THE DISTANCE THE SCOPE TRAVELS INTO THE SMALL INTESTINE AND THE POTENTIAL FOR SUBSEQUENT LOOPING IN THE STOMACH. THE SCOPE DIALS BREAKING DIDN'T CAUSE THE MUCOSAL INJURY. CORRECT ENDOSCOPE FUJINON INC. MEDICAL DIVISION COLONOSCOPE DOUBLE BALLOON ENDOSCOPY MODEL EN-450T5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263341 FUJINON ENDOSCOPE, FIBER OPTIC GDB FUJIFILM MEDICAL SYSTEMS U.S.A., INC. EN-450T5

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR