BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 17348846 · Received July 19, 2023

    Report

    Report Number
    3001845648-2023-00559
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 29, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002557366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.

    Description of Event or Problem · 0

    WHEN DOCTOR TRIED FINISHES THE PROCEDURE AND UNSCREW THE EUS NEEDLE OUT FROM THE SCOPE'S CHANNEL, THE NEEDLE KIND OF STUCK WITH THE METAL HUB OF THE CHANNEL AND CAUSED DISLODGING OF THE METAL HUB FROM THE SCOPE. DOCTOR SUCCESSFULLY SEPARATED THE TWO PARTS AND CARRIED ON WITH PROCEDURE. THEY MADE TOTAL 3 INSERTS OF THE NEEDLE AND EVERY TIME CAUSED THE SAME ISSUE.

    Description of Event or Problem · 0

    FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39372 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1950599 10827002557366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown