BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6148644 · Received December 6, 2016

    Report

    Report Number
    3007591333-2016-00065
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS BLEEDING IN THE CAECUM. THE USER STATED THAT THE SITE OF BLEEDING DID NOT POSE A SIGNIFICANT RISK TO THE PATIENT AND THAT NO INTERVENTION WAS REQUIRED. THE USER ALSO STATED THAT THE SCOPE WAS NOT FOUND TO HAVE ANY DAMAGE OR DEFECT UPON INSPECTION DURING CLEANING AFTER THE PROCEDURE. THERE WAS NO FURTHER PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799988 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C

    Patients

    Seq Age Sex Outcome Treatment
    1