BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 12623187 · Received October 13, 2021

    Report

    Report Number
    12623187
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 28, 2021
    Report Date
    September 30, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED. PATIENT WAS DILATED WITH A 48 FRENCH SAVORY. SURGEON REPORTED PERFORATION WHEN REASSESSING ESOPHAGUS. PROCEDURES WAS ABORTED. IT WAS FOUND THAT THE CLEANGUIDE¿ DISPOSABLE OTW ESOPHAGEAL DILATORS AND MARKED SPRING TIP GUIDEWIRE KINKED DURING THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521236 N/A BRUSH, BIOPSY, GENERAL PLASTIC SURGERY GEE CONMED CORPORATION 000150 202106164

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Other