BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6294813 · Received February 1, 2017

    Report

    Report Number
    3007591333-2017-00010
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    December 23, 2016
    Report Date
    February 1, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED TO UNDERGO TECHNICAL EVALUATION BY THE DISTRIBUTOR AND ALL FUNCTIONAL ASPECTS WERE FOUND TO BE WORKING PROPERLY. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE MANUFACTURER SERVICE CENTER FOR ADDITIONAL TECHNICAL EVALUATION, WHICH WAS PERFORMED IN FOUR PHASES: STANDARD INCOMING ANALYSIS, IN DEPTH FUNCTIONAL TESTING, PARTIAL DISASSEMBLY AND COMPONENT TESTING, AND COMPLETE DISASSEMBLY AND TESTING OF COMPONENTS ASSOCIATED WITH THE ANGULATION SYSTEM. NO EVIDENCE WAS FOUND THAT A TECHNICAL FAILURE MAY HAVE PREVENTED THE DEVICE TO REVERSE FROM A RETROFLEX POSITION DURING ITS INTENDED USE, AND NO POTENTIAL ROOT CAUSE WAS DISCOVERED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POLYPECTOMY COMPLETION, THE PHYSICIAN EXPERIENCED RESISTANCE DURING THE FINAL STAGE OF THE COLONOSCOPY WHEN ATTEMPTING TO WITHDRAW THE ENDOSCOPE, BEGINNING AT APPROXIMATELY 60 CM DISTANCE FROM THE ANUS. ACCORDING TO THE REPORT, THE ENDOSCOPE BECAME STUCK IN THE RETROFLEX POSITION AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77924 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization