BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 7406889 · Received April 9, 2018

    Report

    Report Number
    3001845648-2018-00167
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 10, 2018
    Report Date
    April 9, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002534087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP VIGILANCE REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. IN LINE WITH ISO14971: 2012, UPDATES WERE MADE TO CIRLS RISK MANAGEMENT SYSTEM IN NOVEMBER 2017. THESE UPDATES INCLUDED THE REQUIREMENT TO IDENTIFY THE INITIAL PROBABILITY OF OCCURRENCE AND THE INDIVIDUAL RISK LEVELS ASSOCIATED WITH EACH HAZARD AND HAZARDOUS SITUATION. AS A RESULT OF THE SYSTEM UPDATES THE RISK DOCUMENTATION HAS BEEN REVISED. THE SEVERITY ASSOCIATED WITH THE HAZARDOUS SITUATION HAS NOT CHANGED HOWEVER THE IDENTIFIED RISK LEVELS ASSOCIATED WITH DISTAL AND PROXIMAL NEEDLE KINKS ON ECHO EBUS DEVICES HAVE REDUCED, AND ARE NOW IDENTIFIED AS PRESENTING A LOW RISK TO THE PATIENT OR END-USER. 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.

    Description of Event or Problem · 0

    THE TIP OF THE NEEDLE GOT KINK WHEN TRYING TO TAKE SAMPLE FROM THE SUSPECTED LESION. THE CASE WAS COMPLETED WITH THE HELP OF COOK'S ANOTHER EBUS NEEDLE.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. IN LINE WITH ISO14971: 2012, UPDATES WERE MADE TO CIRLS RISK MANAGEMENT SYSTEM IN NOVEMBER 2017. THESE UPDATES INCLUDED THE REQUIREMENT TO IDENTIFY THE INITIAL PROBABILITY OF OCCURRENCE AND THE INDIVIDUAL RISK LEVELS ASSOCIATED WITH EACH HAZARD AND HAZARDOUS SITUATION. AS A RESULT OF THE SYSTEM UPDATES THE RISK DOCUMENTATION HAS BEEN REVISED. THE SEVERITY ASSOCIATED WITH THE HAZARDOUS SITUATION HAS NOT CHANGED HOWEVER THE IDENTIFIED RISK LEVELS ASSOCIATED WITH DISTAL AND PROXIMAL NEEDLE KINKS ON ECHO EBUS DEVICES HAVE REDUCED, AND ARE NOW IDENTIFIED AS PRESENTING A LOW RISK TO THE PATIENT OR END-USER. A MALFUNCTION PRECEDENCE DOES NOT EXIST FOR THIS FAILURE MODE AND NO SERIOUS INJURY OCCURRED - DOES NOT MEET THE CRITERIA OF A MALFUNCTION REPORT. THE TIP OF THE NEEDLE GOT KINK WHEN TRYING TO TAKE SAMPLE FROM THE SUSPECTED LESION. THE CASE WAS COMPLETED WITH THE HELP OF COOK'S ANOTHER EBUS NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250075 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G53408 00827002534087

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR