BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENDOFLIP CATHETER

    MDR report key: 8708377 · Received June 18, 2019

    Report

    Report Number
    3006897778-2019-00009
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 18, 2019
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SCREEN SHOWED 51 DEGREES AND THE NEXT STEP STOPPED. THE CATHETER WAS USED IN PATIENT. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. A REPEAT PROCEDURE WAS NEEDED. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499721 UNKNOWN ENDOFLIP CATHETER FFX CROSPON LTD UNKNOWN ENDOFLIP CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1