BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS GIF-H190 GASTROSCOPE

    MDR report key: 8711942 · Received June 18, 2019

    Report

    Report Number
    MW5087429
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 14, 2019
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    NWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DISTAL OBLIQUE ATTACHMENT MH-588 TIP FOR THE OLYMPUS GIF-H190 GASTROSCOPE (B)(4) IS NOTED TO CLIP IN USE WHICH CAN RESULT IN RISK OF DISLODGEMENT DURING THE PROCEDURE. ADD'L MEASURES TO SECURE HAVE BEEN NOTED BY PHYSICIAN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499882 OLYMPUS GIF-H190 GASTROSCOPE ENDOSCOPE, ACCESSORIES, NARROW BAND, SPECTRUM NWB OLYMPUS SURGICAL TECHNOLOGIES AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other