BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 7360876 · Received March 22, 2018

    Report

    Report Number
    3001845648-2018-00143
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 18, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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). THE ECHO-HD-22-EBUS-O DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. HOWEVER THE DEVICE WAS LOCATED OUTSIDE OF THE PACKAGING. THE RETURNED DEVICE(ECHOTIP PROCORE 22) WAS NOT MATCHING THE PACKAGING (ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE). 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. 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.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THE ECHO-HD-22-EBUS-O DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. HOWEVER THE DEVICE WAS LOCATED OUTSIDE OF THE PACKAGING. THE RETURNED DEVICE(ECHOTIP PROCORE 22) WAS NOT MATCHING THE PACKAGING (ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE), THEREFORE ADDITIONAL INFORMATION WAS REQUESTED. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    REP ADVISED THAT THE STILLED WOULD RUN THROUGH THE DEVICE AFTER THEIR FIRST PASS. "AS PER COMPLAINT FORM": FIRST PASS SUCCESSFUL HOWEVER STYLET WOULD NOT ENTER BACK INTO THE BORE OF THE NEEDLE AGAIN.

    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. REP ADVISED THAT THE STILLED WOULD RUN THROUGH THE DEVICE AFTER THEIR FIRST PASS "AS PER COMPLAINT FORM": FIRST PASS SUCCESSFUL HOWEVER STYLET WOULD NOT ENTER BACK INTO THE BORE OF THE NEEDLE AGAIN. A PROXIMAL NEEDLE KINK WAS NOTED DURING THE DEVICE EVALUATION.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INFORM THE FDA THAT THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS. REP ADVISED THAT THE STILLED WOULD RUN THROUGH THE DEVICE AFTER THEIR FIRST PASS "AS PER COMPLAINT FORM": FIRST PASS SUCCESSFUL HOWEVER STYLET WOULD NOT ENTER BACK INTO THE BORE OF THE NEEDLE AGAIN. A PROXIMAL NEEDLE KINK WAS NOTED DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204813 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52011 00827002520110

    Patients

    Seq Age Sex Outcome Treatment
    1