BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7057067 · Received November 23, 2017

    Report

    Report Number
    3001845648-2017-00558
    Event Type
    Malfunction
    Date Received
    November 23, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 23, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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 PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE FIXING SCREW IS BROKEN.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # 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 REPORT. IT HAS BEEN CONFIRMED AND CLARIFIED THAT THE 'NON-RETRACTION OF NEEDLE' PRECEDENCE DOES NOT APPLY FOR THIS COMPLAINT AS THE NEEDLE WAS EXPOSED ON RETURN DUE TO THE SCREW BEING SET AT MARK 3. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE FIXING SCREW IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835922 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34279 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1