BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 10273416 · Received July 14, 2020

    Report

    Report Number
    3001845648-2020-00425
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Report Date
    September 2, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002557380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510 K # - K142688. CANCELLATION REPORT BEING SUBMITTED AS IT HAS BEEN DETERMINED THAT THE KINK IN NEEDLE HANDLE AND PROXIMAL NEEDLE BREAK ARE RELATED TO THE STYLET ISSUES WHICH WILL BE CAPTURED IN CIRL REF # (B)(4). THEREFORE THIS FILE IS NO LONGER REQUIRED.

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED AS IT HAS BEEN DETERMINED THAT THE KINK IN NEEDLE HANDLE AND PROXIMAL NEEDLE BREAK ARE RELATED TO THE STYLET ISSUES WHICH WILL BE CAPTURED IN CIRL REF # (B)(4). THEREFORE THIS FILE IS NO LONGER REQUIRED.

    Additional Manufacturer Narrative · 1

    510 K # - K142688. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NEEDLE AND SHEATH BREAKAGE OBSERVED DURING LAB EVALUATION OF PR (B)(4) CARRIED OUT ON THE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736935 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1600252 10827002557380

    Patients

    Seq Age Sex Outcome Treatment
    1