BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7498134 · Received May 9, 2018

    Report

    Report Number
    3001845648-2018-00211
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 5, 2018
    Report Date
    May 9, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510K) 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

    510K) 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 ASSUMPTION THAT SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE BROKEN NEEDLE. HOWEVER, FOLLOWING THE DEVICE EVALUATION THE NEEDLE WAS FULLY INTACT AND A PROXIMAL NEEDLE KINK WAS PRESENT. OVERALL RISK ASSESSED AS CATEGORY IIA (LOW). 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

    NEEDLE BROKE INTO PIECES WHEN PULLING BACK FROM THE ENDOSCOPE. "AS PER COMPLAINT FORM": THE NEEDLE BROKE INTO PIECES WHEN THE PHYSICIAN THE NEEDLE PULL BACK FROM THE ENDOSCOPE.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. NEEDLE BROKE INTO PIECES WHEN PULLING BACK FROM THE ENDOSCOPE. "AS PER COMPLAINT FORM": THE NEEDLE BROKE INTO PIECES WHEN THE PHYSICIAN THE NEEDLE PULL BACK FROM THE ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341999 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34279 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention