BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 8304919 · Received February 5, 2019

    Report

    Report Number
    1820334-2019-00352
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Report Date
    February 5, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: INSTRUMENT, BIOPSY; BIOPSY NEEDLE KIT. D2 PROCODE: KNW. 510K#: K973565. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THOUGH THE ROOT CAUSE IN THIS CASE WAS NOT ESTABLISHED, A PAST COMPLAINT FOR A SIMILAR DEVICE AND FAILURE MODE CONCLUDED THAT THE MAIN CAUSE OF FAILURE IS MANUFACTURING-RELATED, ALTHOUGH THIS COULD NOT BE CONFIRMED AS NO COMPLAINT DEVICE WAS RETURNED TO AID IN OUR INVESTIGATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE INTERNATIONAL CUSTOMER WAS UNABLE TO START USING THE NEEDLES WITHOUT USING WHAT WAS BELIEVED TO BE AN INORDINATE AMOUNT OF FORCE. AFTER THE APPLICATION OF THIS FORCE, THE COMPLAINT DEVICE WAS DEPLOYED AND THE PROCEDURES WERE SUCCESSFULLY COMPLETED. IT WAS DISCOVERED DURING THE INVESTIGATION PORTION OF THE EVALUATION OF THIS INCIDENT THAT THE FAILURE MODE AS REPORTED BY THE CUSTOMER LIKELY DESCRIBES A DIFFICULTY IN SEPARATING THE NEEDLE AND THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98611 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW COOK INC N/A 8770784 00827002087286

    Patients

    Seq Age Sex Outcome Treatment
    1