BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 4935719 · Received July 20, 2015

    Report

    Report Number
    3007591333-2015-00028
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 20, 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 INVESTIGATION AT THE ENDOCHOICE SERVICE CENTER DETERMINED THAT A BASE BOARD, A CIRCUIT BOARD, AND A HARD DRIVE IN THE VIDEO PROCESSOR HAD FAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ENDOSCOPY, THE VIDEO PROCESSOR UNIT SHUT DOWN, RESULTING LOSS OF ALL DISPLAY CAPABILITY. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468980 FUSE ENDOSCOPY SYSTEM GASTROSCOPE AND ACCESSORIES FDF ENDOCHOICE INC. FUSEBOX NA

    Patients

    Seq Age Sex Outcome Treatment
    1