BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6458087 · Received April 4, 2017

    Report

    Report Number
    3007591333-2017-00024
    Event Type
    Injury
    Date Received
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS BY THE MANUFACTURER TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORT HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION ABOUT THE CASE(S) OR DEVICE(S) IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT "A FEW PERFS" HAD OCCURRED DURING UNSPECIFIED CASES, WHICH MAY OR MAY NOT HAVE BEEN DIRECTLY ASSOCIATED WITH USE OF FUSE SCOPES. NO ADDITIONAL INFORMATION REGARDING THE INCIDENCES, PATIENT OUTCOMES, OR THE DEVICES INVOLVED WAS INCLUDED IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239986 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other