BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7272850 · Received February 15, 2018

    Report

    Report Number
    3001845648-2018-00066
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    December 4, 2017
    Report Date
    February 15, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. A CONSERVATIVE ASSESSMENT DEEMED THIS EVENT REPORTABLE BASED ON THE NEEDLE KINKING PROXIMALLY. HOWEVER, FOLLOWING DEVICE EVALUATION THE BEND WAS CONFIRMED TO NOT BE A KINK. 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. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: " DURING AN EBUS, ENDOBRONCHIAL ULTRASOUND, PROCEDURE THE ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE WAS USED. THE STYLET ONCE REMOVED FROM NEEDLE WOULD NOT GO BACK INTO THE NEEDLE. THE PHYSICIAN WAS COMPLETED WITH THE PROCEDURE SO NO ADDITIONAL DEVICE WAS NEEDED. THE SPECIMEN ALREADY IN THE NEEDLE WAS ABLE TO BE REMOVED TO GET A DIAGNOSIS. THERE WAS NO HARM TO THE PATIENT."

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. AS REPORTED TO CUSTOMER RELATIONS: " DURING AN EBUS, ENDOBRONCHIAL ULTRASOUND, PROCEDURE THE ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE WAS USED. THE STYLET ONCE REMOVED FROM NEEDLE WOULD NOT GO BACK INTO THE NEEDLE. THE PHYSICIAN WAS COMPLETED WITH THE PROCEDURE SO NO ADDITIONAL DEVICE WAS NEEDED. THE SPECIMEN ALREADY IN THE NEEDLE WAS ABLE TO BE REMOVED TO GET A DIAGNOSIS. THERE WAS NO HARM TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117899 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1