BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-USE MARKED SPRING TIP GUIDEWIRE

    MDR report key: 10104726 · Received June 1, 2020

    Report

    Report Number
    10104726
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    April 23, 2020
    Report Date
    May 21, 2020
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    OCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EGD (ESOPHAGOGASTRODUODENOSCOPY) GUIDEWIRE KINKED AT SOME POINT DURING ITS REMOVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570596 SINGLE-USE MARKED SPRING TIP GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY MICRO-TECH (NAN JING) CO., LTD. M190917103

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA