BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6021039 · Received October 12, 2016

    Report

    Report Number
    3007591333-2016-00051
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INSPECTION OF THE DEVICE AT THE SERVICE CENTER, THE ISSUE WAS ATTRIBUTED TO A DENTED OR PUNCTURED INSERTION TUBE. THE DEVICE WAS REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANGULATION OF THE COLONOSCOPE WAS TOO TIGHT. BLEEDING RESULTED WHEN RETRO-FLEXING OF THE SCOPE AT THE RECTUM WAS BEING REVERSED. TWO CLIPS WERE USED TO STOP THE BLEEDING. THERE WAS NO FURTHER PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671890 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention