BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON DBE SCOPE OVERTUBE

    MDR report key: 7518010 · Received May 15, 2018

    Report

    Report Number
    MW5077223
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 10, 2018
    Manufacturer
    FUJINON / FUJIFILM MEDICAL SYSTEMS USA, INC.
    Product Code
    FDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN BEGAN WITHDRAWING THE FUJINON DBE SCOPE (B)(4), THE FUJINON CART REGISTERED THAT THE BALLOONS ON THE OVERTUBE (TS13140, LOT 1709B2, EXP 08/31/2019) AND ON THE SCOPE WERE DEFLATED. AS THEY WERE WITHDRAWING, THEY NOTICED SOME RESISTANCE, SO THE MD AND THE ENDOSCOPY TECH CONFIRMED THAT THE BALLOONS WERE DEFLATED. UPON WITHDRAWING THE SCOPE, THEY FOUND THAT THE BALLOON ON THE OVERTUBE WAS STILL INFLATED. THIS CAUSED SIGNIFICANT IRRITATION AND SOME ESOPHAGEAL BLEEDING UPON WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358500 FUJINON DBE SCOPE OVERTUBE ENTEROSCOPE AND ACCESSORIES FDA FUJINON / FUJIFILM MEDICAL SYSTEMS USA, INC. TS13140 1709B2

    Patients

    Seq Age Sex Outcome Treatment
    1