BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANGUIDE

    MDR report key: 16894579 · Received May 9, 2023

    Report

    Report Number
    16894579
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 2, 2023
    Manufacturer
    CONMED CORPORATION
    Product Code
    OCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD MULTIPLE INCIDENTS WHERE CONMED DISPOSABLE GUIDE WIRES HAVE SNAPPED PARTIALLY THROUGH. THIS ISSUE HAS INVOLVED AT LEAST 2 DIFFERENT LOT NUMBERS THAT WE ARE AWARE OF. PRIOR TO TODAY, THAT LOT NUMBER WAS PICKED UP BY THE COMPANY'S REPRESENTATIVE, EXCHANGED AND INVOLVED WIRE TAKEN. THE WIRES INVOLVED IN TODAY'S INCIDENT ARE IN PROCESSION OF THE HOSPITAL. THE CONCERN IS THAT IF THIS PRODUCT WERE TO BREAK FURTHER INTO THE PROCEDURE IT COULD CAUSE AN INJURY OR PERFORATION IN THE ESOPHAGUS AND OR STOMACH OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800826 CLEANGUIDE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY CONMED CORPORATION DIS150 202211184

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Female