BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 16626561 · Received March 28, 2023

    Report

    Report Number
    3001845648-2023-00188
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 30, 2022
    Report Date
    October 18, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 THIS SUPPLEMENTAL REPORT IS BEING SENT AS A CANCELLATION REPORT AS ON THE 18-OCT-2023 ENGINEERING INPUT CONFIRMED THAT THE PROXIMAL BREAK OBSERVED DURING THE LAB EVALUATION OF THE ORIGINAL FILE (PR (B)(4) EMDR 3001845648-2022-00519) LIKELY OCCURRED DURING THE RETURNS PROCESS AND THEREFORE DID NOT WARRANT AN ADDITIONAL FILE TO BE OPENED CAPTURING THIS PROXIMAL BREAK" AND "BASED ON CUSTOMER FEEDBACK THAT THE KINKS AND BREAKS WERE NOT PRESENT PRIOR TO RETURN TO CIRL THIS COMPLAINT CAN BE CANCELLED".

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SENT AS A CANCELLATION REPORT AS ON THE 18-OCT-2023 ENGINEERING INPUT CONFIRMED THAT THE PROXIMAL BREAK OBSERVED DURING THE LAB EVALUATION OF THE ORIGINAL FILE (PR 365677 EMDR 3001845648-2022-00519) LIKELY OCCURRED DURING THE RETURNS PROCESS AND THEREFORE DID NOT WARRANT AN ADDITIONAL FILE TO BE OPENED CAPTURING THIS PROXIMAL BREAK" AND "BASED ON CUSTOMER FEEDBACK THAT THE KINKS AND BREAKS WERE NOT PRESENT PRIOR TO RETURN TO CIRL THIS COMPLAINT CAN BE CANCELLED".

    Description of Event or Problem · 0

    PROXIMAL BREAK BELOW THE SHEATH EXTENDER OBSERVED ON 01 OF THE 03 DEVICES DURING THE LAB EVALUATION OF (B)(4). PATIENT OUTCOME: DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY?: NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE?: NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)?: NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE?: NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480374 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1907991 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown