BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5107985 · Received September 21, 2015

    Report

    Report Number
    3007591333-2015-00047
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 21, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPE WAS RETURNED TO THE ENDOCHOICE SERVICE CENTER FOR EVAL AND REPAIR. IT WAS FOUND THAT THE ENDOSCOPE DID NOT ANGULATE PROPERLY AND THE ELECTRICAL CONNECTOR OF THE ENDOSCOPE HAD FLUID INVASION.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE, IT WAS REPORTED BY THE MEDICAL FACILITY THAT THERE WAS COMPLETE IMAGE LOSS WHEN THE ENDOSCOPE WAS ANGULATED. THE CASE WAS CONCLUDED WITH ANOTHER COLONOSCOPE. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCES TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623547 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE INC. 1C NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1