BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 6084896 · Received November 8, 2016

    Report

    Report Number
    3001845648-2016-00319
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. A REVIEW OF THE QC RECORDS FOR QC # (B)(4) DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT (B)(6). A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C DEVICES OF LOT# C1264155 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO NEEDLES HAVE BROKEN IN THE PATIENT DURING THE FIRST ATTEMPT OF USE. THE BROKEN TIPS WERE REMOVED FROM THE BODY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT. THE NEEDLES HAVE BEEN DISPOSED OF. THIS REPORT REFERENCES ONE OF THE NEEDLES BREAKAGES. REFERENCE ALSO REPORT# 3001845648-2016-00318.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738087 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention