BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7189293 · Received January 15, 2018

    Report

    Report Number
    3001845648-2018-00020
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 24, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). LAB EVALUATION WAS CONDUCTED ON THE 24 JAN 18 AND THIS EVENT IS NOT A REPORTABLE EVENT. THIS REPORT WAS SUBMITTED AS FDA MDR REPORTABLE CONSERVATIVELY BASED ON THE DEVICE MALFUNCTION "NEEDLE KINKS PROXIMALLY (BELOW THE SLIDING SHEATH ADJUSTER)" . HOWEVER BASED ON THE LABORATORY EVALUATION NO NEEDLE KINKING WAS NOTED. THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION REPORT.

    Description of Event or Problem · 0

    LAB EVALUATION WAS CONDUCTED ON THE 24 JAN 18 AND THIS EVENT IS NOT A REPORTABLE EVENT. THIS REPORT WAS SUBMITTED AS FDA MDR REPORTABLE CONSERVATIVELY BASED ON THE DEVICE MALFUNCTION "NEEDLE KINKS PROXIMALLY (BELOW THE SLIDING SHEATH ADJUSTER)" . HOWEVER BASED ON THE LABORATORY EVALUATION NO NEEDLE KINKING WAS NOTED. THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON THE SECOND PASS THE DOCTOR POINTED OUT THE BEND OF THE NEEDLE AT THE HANDLE END. THE SECOND AND THIRD PASS BECAME MORE DIFFICULT TO ATTACH AND DETACH. BY THE FOURTH PASS HE WAS UNABLE TO ATTACH THE NEEDLE. HE FINISHED THE CASE WITH A 22G PROCORE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33367 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34785 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1