BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5418979 · Received February 1, 2016

    Report

    Report Number
    3007591333-2016-00004
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 28, 2016
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PROBLEM WITH THE EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TEAR OF A POLYP MASS TO THE MUSCULAR TISSUE OCCURRED DURING A COLONOSCOPY. TISSUE BROKE APART EASILY. TWO CLIPS WERE USED AT THE TIME OF DISCOVERY TO CLOSE THE OPENING TO THE MUSCULATURE. A BIOPSY WAS TAKEN AND THE COLONOSCOPY WAS INTERRUPTED PENDING ITS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61446 FUSE ENDOSCOPY SYSTEM FDF ENDOCHOICE INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention