BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6199143 · Received December 22, 2016

    Report

    Report Number
    3007591333-2016-00069
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER WHERE THE LEAK TEST WAS REPEATED WITH PASSING RESULTS. EXAMINATION OF DEVICE REVEALED NO ISSUES WHICH COULD BE RELATED TO PATIENT INJURY. MAINTENANCE ACTIVITIES PERFORMED ON DEVICE BY MANUFACTURER SERVICE CENTER INCLUDED REPAIR OF DENTED LIGHT GUIDE TUBE, AND REPLACEMENT OF AIR/WATER SEPARATOR O-RINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-PROCEDURE COLITIS AND INFECTION, WHICH REQUIRED HOSPITALIZATION. POTENTIAL CONTRIBUTING FACTORS WERE PRE-EXISTING MEDICAL CONDITIONS WHICH INCLUDED THE PRESENCE OF H. PYLORI, ULCER DISEASE, AND POSSIBLE CONGESTIVE HEART FAILURE. THE PATIENT WAS REPORTED AS THE FOURTH OF SIX PATIENTS WHO UNDERWENT PROCEDURES USING THE DEVICE, AND THE ONLY PATIENT WHO PRESENTED WITH SYMPTOMS POST-PROCEDURE. THE DEVICE WAS REPORTED TO HAVE BEEN REPROCESSED AT THE HOSPITAL ACCORDING TO MANUFACTURER RECOMMENDATION AND HAD NO SYSTEM FAILURE; DURING FOLLOW UP, THE DEVICE WAS ALSO REPORTED TO HAVE PASSED A LEAK TEST PERFORMED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851000 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization