BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 11516885 · Received March 18, 2021

    Report

    Report Number
    3001845648-2021-00193
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 21, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. A CONSERVATIVE ASSESSMENT WAS INITIALLY CARRIED OUT UNDER THE ASSUMPTION THE DISTAL NEEDLE OF THE DEVICE BROKE. ADDITIONAL INFORMATION WAS RECEIVED 21-APR-2021 CONFIRMING THERE WAS NO ISSUE WITH THE NEEDLE TIP AND THAT THE STYLET CAP BROKE. A RE-ASSESSMENT WAS CARRIED OUT BASED ON THIS ADDITIONAL INFORMATION AND THE OVERALL RISK OF THIS FAILURE IS LOW. THIS FILE NO LONGER MEETS THE CRITERIA OF AN FDA "SERIOUS INJURY" REPORT OR "MALFUNCTION" REPORT AS PER FDA GUIDELINES "MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)". NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    A CONSERVATIVE ASSESSMENT WAS INITIALLY CARRIED OUT UNDER THE ASSUMPTION THE DISTAL NEEDLE OF THE DEVICE BROKE. ADDITIONAL INFORMATION WAS RECEIVED 21-APR-2021 CONFIRMING THERE WAS NO ISSUE WITH THE NEEDLE TIP AND THAT THE STYLET CAP BROKE. A RE-ASSESSMENT WAS CARRIED OUT BASED ON THIS ADDITIONAL INFORMATION AND THE OVERALL RISK OF THIS FAILURE IS LOW. THIS FILE NO LONGER MEETS THE CRITERIA OF AN FDA "SERIOUS INJURY" REPORT OR "MALFUNCTION" REPORT AS PER FDA GUIDELINES "MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿" NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. NO DEVICE MALFUNCTION EXISTS FOR STYLET BREAKING. THIS SUPPLEMENT REPORT IS BEING SUBMITTED AS A CANCELLATION MDR.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K142688. (B)(4). THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS PER SOURCE DOC: "DURING THE PROCEDURE THE END OF THE NEEDLE BROKE. PATIENT WAS NOT HURT AND THE PRODUCT IS AVAILABLE FOR RETURN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408359 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1759620 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1