BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 4902625 · Received July 2, 2015

    Report

    Report Number
    3007591333-2015-00024
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    April 28, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    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 DEVICE HAS SHUT DOWN MECHANISMS IN THE EVENT OF OVER-CURRENT. IT IS NOT KNOWN WHETHER THIS EVENT REPRESENTS A MALFUNCTION OR IF THE DEVICE SHUT DOWN AS INTENDED. THE USER INSTALLED AN ISOLATION TRANSFORMER AND THE DEVICE WAS SUBSEQUENTLY REPORTED TO BE FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    THE USER REPORTED AN ELECTRICAL BURNING SMELL IMMEDIATELY PRIOR TO A COLONOSCOPY CASE, FOLLOWED BY THE VIDEO PROCESSOR UNIT SHUTTING ITSELF OFF. THE PATIENT HAD NOT YET BEEN SEDATED AT THE TIME OF THIS EVENT. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO THE 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
    433302 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE INC. FUSEBOX NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1