BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6575386 · Received May 18, 2017

    Report

    Report Number
    3001845648-2017-00181
    Event Type
    Injury
    Date Received
    May 18, 2017
    Report Date
    July 6, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 PMA/510(K) #K160229 THIS COMPLAINT IS RELATED TO AN ECHOTIP PROCORE ENDOSCOPIC ULTRASOUND NEEDLE OF AN UNKNOWN LOT NUMBER. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN TO COOK IRELAND FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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 CONFIRMED BASED ON THE CUSTOMER TESTIMONY. AS THE ECHO DEVICE WAS NOT RETURNED FOR EVALUATION AND NO SPECIFIC DEVICE MALFUNCTION WAS NOTED DURING THE PROCEDURE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE MANUFACTURING RECORDS OF THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS EXCESSIVE BLEEDING, MORE BLEEDING THAN NORMAL." DISTRICT MANAGER CONFIRMED ON 05MAY2017 THIS OCCURRED DURING THE PROCEDURE. AND THAT THE PHYSICIAN WILL NOT PROVIDE ANY FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #K160229. COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). NO UPDATE TO INVESTIGATION CONCLUSIONS PROVIDED IN INITIAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: "DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS EXCESSIVE BLEEDING, MORE BLEEDING THAN NORMAL." DISTRICT MANAGER CONFIRMED ON (B)(6) 2017 THIS OCCURRED DURING THE PROCEDURE, AND THAT THE PHYSICIAN WILL NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356082 UNKNOWN FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening