BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5035716 · Received August 20, 2015

    Report

    Report Number
    3007591333-2015-00038
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 19, 2015
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDS
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A COLONOSCOPY, THE PROCESSOR UNIT STOPPED FUNCTIONING. THE DISPLAYED IMAGE COULD NOT BE OBTAINED UNTIL THE SYSTEM WAS DISCONNECTED AND REBOOTED. THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552147 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDS ENDOCHOICE, INC. FUSEBOX NA

    Patients

    Seq Age Sex Outcome Treatment
    1