BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE 1C

    MDR report key: 6848770 · Received September 7, 2017

    Report

    Report Number
    3007591333-2017-00044
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 14, 2017
    Report Date
    September 7, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS AVAILABLE FROM THE USER SITE. THE PATIENT WAS UNABLE TO DETERMINE IF HIS SYMPTOMS WERE RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER SERVICE LINE OF THE MANUFACTURER WAS CONTACTED BY A PATIENT 3 WEEKS POST-PROCEDURE. THE PATIENT REPORTED THAT HE STILL DID NOT FEEL WELL AFTER HIS COLONOSCOPY. HIS SYMPTOMS INCLUDED MUCOUS DISCHARGE (IMMEDIATELY POST-PROCEDURE) AND ABDOMINAL PAIN. HE WAS UNABLE TO DETERMINE IF HIS SYMPTOMS WERE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630260 FUSE 1C COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FSC-3300-ST

    Patients

    Seq Age Sex Outcome Treatment
    1 Other