BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5060640 · Received September 4, 2015

    Report

    Report Number
    3007591333-2015-00041
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 6, 2015
    Report Date
    September 4, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDS
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICE AT THE MFR'S REPAIR SITE FOUND THAT THE CAMERA ASSEMBLY IN THE DISTAL TIP OF THE ENDOSCOPE REQUIRED REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE DISPLAY ON THE MONITOR TURNED WHITE WHEN THE COLONOSCOPE WAS ANGULATED. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO ANY PT, AS THIS OCCURRED PRIOR TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587865 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDS ENDOCHOICE INC. FUSE 1C NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1