BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 6901915 · Received September 28, 2017

    Report

    Report Number
    1820334-2017-03267
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 14, 2017
    Report Date
    February 12, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002282926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/F 510K #: K973565. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED REPRESENTATIVE DEVICES WERE CONDUCTED DURING THE INVESTIGATION, AND NO ISSUES WERE FOUND RELATED TO THE REPORTED ISSUE. THE VISUAL INSPECTION OF THE RETURNED, UNOPENED, AND REPRESENTATIVE DEVICES CONFIRMED THAT THERE WAS NO DAMAGE TO THE SURFACE OF THE QUICK CORE BIOPSY NEEDLES WITHIN THE LABELED PACKAGES. ALL UNUSED AND UNOPENED DEVICES APPEARED TO HAVE GOOD FORMALITY. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER, AND THE COMPLAINT WAS RELATED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, ON (B)(6) 2017, WHEN THE SURGEON WAS RINSING A QUICK-CORE COAXIAL BIOPSY NEEDLE, THE DEVICE ENGAGED SUDDENLY, AND RESULTED IN THE BREAKAGE OF THE DEVICE. THE SURGEON WAS NOT ABLE TO REUSE THE PRODUCT, SO IT WAS THROWN IN THE TRASH, AND ANOTHER PRODUCT FROM A DIFFERENT LOT WHICH WAS IN THE CUSTOMER'S INVENTORY WAS EMPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTEDLY FINE, AND THE CUSTOMER CONFIRMED THAT NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THE BIOPSY WAS REPORTEDLY COMPLETED SAFELY AND NO PATIENT ADVERSE EVENTS WERE EXPERIENCED. THE RADIOLOGIST FELT THE PATIENT WAS UNCOMFORTABLE AND WAS NOT SATISFIED WITH THE NEEDLE. ANOTHER PHYSICIAN STATED THE NEEDLE WAS NOT AS SHARP AS USUAL. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE COMPLAINT PRODUCT WERE NOT REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682260 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002282926

    Patients

    Seq Age Sex Outcome Treatment
    1