BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOVE DC CUTTER SET 12

    MDR report key: 17949565 · Received October 16, 2023

    Report

    Report Number
    MW5147001
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 10, 2023
    Manufacturer
    OVESCO ENDOSCOPY AG
    Product Code
    QAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING UPPER GI ENDOSCOPY TO REMOVE ESOPHAGEAL STENT, ONE OF THE THREE PRONGS ON THE END OF THE "REMOVE DC CUTTER SET 12" BROKE OFF AND WAS NOT RETRIEVABLE IN THE PROCEDURE. NO HARM WAS DETERMINED AND THE PATIENT WILL PASS THE SMALL PIECE ACCORDING TO THE PROVIDER. THIS IS BEING REPORTED VOLUNTARILY ON THE 3500 FORM ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66196 REMOVE DC CUTTER SET 12 ENDOSCOPIC ELECTROSURGICAL CLIP CUTTING SYSTEM QAG OVESCO ENDOSCOPY AG 843696

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male