BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 6244026 · Received January 11, 2017

    Report

    Report Number
    3007591333-2017-00001
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ENDOCHOICE, INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER. THE INVESTIGATION DID NOT IDENTIFY ANY ANOMALIES WITH THE DEVICE THAT WOULD PREVENT SUCCESSFUL CLEANING AND HIGH-LEVEL DISINFECTION WHEN PERFORMED IN ACCORDANCE WITH VALIDATED INSTRUCTIONS. TESTING SHOWED THAT ANGULATION DID NOT MEET OEM SPECIFICATIONS. REPAIR INCLUDED ADJUSTMENT OF ANGULATION ANGLES TO MEET SPECIFICATION, AND REPLACEMENT OF THE BENDING SHEATH ON THE DISTAL TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A NORMAL COLONOSCOPY WITH NO SPECIMENS COLLECTED, THE PATIENT PRESENTED AT THE EMERGENCY ROOM. BASED ON TESTS PERFORMED AT THE HOSPITAL, THE PATIENT WAS DIAGNOSED WITH COLITIS AND RECEIVED ANTIBIOTIC TREATMENT. ACCORDING TO THE REPORTER, THE SCOPE EMPLOYED TO PERFORM THE COLONOSCOPY WAS USED 38 TIMES BETWEEN (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27005 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE, INC. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization