BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE 1C

    MDR report key: 7096539 · Received December 7, 2017

    Report

    Report Number
    3007591333-2017-00064
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE AUTHORIZED REPAIR CENTER FOR EVALUATION. IT WAS DETERMINED THAT FLUID HAD LEAKED INTO THE DISTAL TIP, CAUSING THE IMAGE MALFUNCTION. THE DEVICE WAS REPAIRED AND RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ENDOSCOPY CASE, THE CENTER DISPLAY SCREEN WOULD INTERMITTENTLY TURN RED OR GREEN, OBSCURING VISUALIZATION OF THE ANATOMY. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874234 FUSE 1C ENDOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FSC-330-F7523

    Patients

    Seq Age Sex Outcome Treatment
    1