BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE SYSTEMS

    MDR report key: 6109867 · Received November 17, 2016

    Report

    Report Number
    3007591333-2016-00059
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 11, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES TRAINER (INITIAL REPORTER) DETERMINED ON SITE THAT A FUSE INSIDE THE ISOLATION TRANSFORMER NEEDED TO BE REPLACED. REPLACEMENT FUSES WERE SENT TO THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMPLETE LOSS OF POWER DURING A PROCEDURE RESULTING IN LOSS OF ALL IMAGES. THERE WAS NO PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762140 FUSE SYSTEMS COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE SYSTEMS NA

    Patients

    Seq Age Sex Outcome Treatment
    1