BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 7472137 · Received April 30, 2018

    Report

    Report Number
    3001845648-2018-00196
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 1, 2018
    Report Date
    April 30, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. A CONSERVATIVE ASSESSMENT DEEMED THIS EVENT REPORTABLE BASED ON THE MALFUNCTION PRECEDENCE "DISTAL TIP NEEDLE/ SHEATH PERFORATION". HOWEVER, FOLLOWING THE DEVICE EVALUATION NO PERFORATION WAS OBSERVED. 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

    THE NEEDLE AND SHEATH "SEPARATED" AFTER FIRST "ATTEMPT" WHICH AFFECTED SECOND BIOPSY. OPERATOR CHANGED ANOTHER SAME PRODUCT TO FINISH THE BIOPSY.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. THE NEEDLE AND SHEATH SEPERATED AFTER FIRST ATTEMP WHICH AFFECTED SECOND BIOPSY. OPERATOR CHANGED ANOTHER SAME PRODUCT TO FINISH THE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316747 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52011 00827002520110

    Patients

    Seq Age Sex Outcome Treatment
    1