BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 4960921 · Received July 31, 2015

    Report

    Report Number
    3007591333-2015-00030
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 31, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDS
    PMA / PMN Number
    K141598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHUT-DOWN OF THE VIDEO PROCESSOR UNIT IS CAUSED BY ACTIVATION OF THE CIRCUIT PROTECTION. THIS OCCURS DUE TO A CURRENT SPIKE ASSOCIATED WITH A COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A COLONOSCOPY, 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 PATIENT. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION THAT THE MEDICAL DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498903 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDS ENDOCHOICE INC. FUSEBOX

    Patients

    Seq Age Sex Outcome Treatment
    1