BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5091436 · Received September 17, 2015

    Report

    Report Number
    3007591333-2015-00045
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED DUE TO PAIN, IN WHICH THE CAUSE WAS FOUND TO BE A SPLENIC TEAR. IT WAS NOTED THAT THE ENDOSCOPIST FELT AS IF THE ENDOSCOPE'S EXCESSIVE FLEXIBILITY MAY HAVE CONTRIBUTED TO THE COMPLICATION. THE PATIENT WAS DISCHARGED HOME AFTER 24 HOURS OF OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616980 FUSE ENDOSCOPY SYSTEM FDF ENDOCHOICE INC. FUSE 1CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization