BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 4902624 · Received July 2, 2015

    Report

    Report Number
    3007591333-2015-00025
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    May 19, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K131422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DETERMINED THAT THE DISTAL TIP OF THE GASTROSCOPE REQUIRED REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER IN A REPAIR SERVICE REQUEST, STATING THAT WHEN ANGULATING THE GASTROSCOPE, ALL IMAGES GO BLACK. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433265 FUSE ENDOSCOPY SYSTEM GASTROSCOPE AND ACCESSORIES FDF ENDOCHOICE INC. FUSE 1G NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1