BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 4926256 · Received July 17, 2015

    Report

    Report Number
    3007591333-2015-00027
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDS
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A COLONOSCOPY, THE DOCTOR HAD DIFFICULTY UNLOCKING THE ANGULATION BRAKE WHEN IT WAS IN THE RETROFLEXED POSITION. A COMPANY REPRESENTATIVE WHO WAS PRESENT UNLOCKED THE BRAKE. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO THE PT. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION THAT THE MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464901 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDS ENDOCHOICE INC. FUSE 1C NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1