BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE 1C COLONOSCOPE

    MDR report key: 3862997 · Received June 5, 2014

    Report

    Report Number
    3010371576-2014-00001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Manufacturer
    ENDOCHOICE INNOVATION CENTER LTD.
    Product Code
    FDF
    PMA / PMN Number
    K132839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE COLONOSCOPE USED IN THE PROCEDURE WAS RETURNED TO THE U.S. SERVICE AND REPAIR CENTER LOCATED IN (B)(4) FOR EVALUATION, AND WAS FOUND TO BE OPERATING NORMALLY. NO DEFECTS OF ANY KIND WERE IDENTIFIED. THE DEVICE UNDERWENT VISUAL INSPECTION FOR DAMAGE AND THE STANDARD FUNCTIONAL INSPECTION, AND WAS RETURNED TO THE END USER.

    Description of Event or Problem · 1

    A COLONOSCOPY PROCEDURE WAS PERFORMED ON A PATIENT WHO WAS EXPERIENCING ABDOMINAL PAIN. DURING ADVANCEMENT OF THE COLONOSCOPE, A PERFORATION OF THE SIGMOID COLON OCCURRED. THE TEAR WAS DETECTED IMMEDIATELY, THE COLONOSCOPY PROCEDURE WAS HALTED AND THE PATIENT UNDERWENT SURGERY TO REPAIR THE PERFORATION. THE PATIENT RECOVERED WELL FROM THE SURGERY AND SHE WAS RELEASED. THERE WAS NO REPORT OF ANY MALFUNCTION OF THE COLONOSCOPE. THE COLONOSCOPE USED IN THE PROCEDURE WAS RETURNED TO THE U.S. SERVICE AND REPAIR CENTER FOR EVALUATION, AND WAS FOUND TO BE OPERATING NORMALLY. NO DEFECTS OF ANY KIND WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329433 FUSE 1C COLONOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE FDF ENDOCHOICE INNOVATION CENTER LTD. FUSE 1C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R