BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 8258111 · Received January 17, 2019

    Report

    Report Number
    1820334-2019-00116
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    October 8, 2018
    Report Date
    January 17, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002270169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K973565. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A DIMENSIONAL VERIFICATION, VISUAL INSPECTION, AND FUNCTIONAL TEST, WERE CONDUCTED DURING THE INVESTIGATION. UPON VISUAL INSPECTION, NO SURFACE DAMAGE WAS FOUND ON THE DEVICE. THE NEEDLE WAS NOT ABLE TO BE UNSCREWED BY HAND, BUT WAS ABLE TO BE REMOVED WITH CHANNEL LOCKS. THE THREADS DID NOT APPEAR DAMAGED. THE DEVICE DIMENSIONS WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. 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 INDICATED NO NON-CONFORMANCE FOR THIS LOT. A REVIEW OF THE RELEVANT SUBASSEMBLIES AND RAW MATERIALS FOUND NO NON-CONFORMANCES. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. A SUPPLIER INVESTIGATION WAS REQUESTED FOR THE RELEVANT SUBASSEMBLY LOTS. NO NON-CONFORMANCES ON THE AFFECTED LOTS WERE FOUND AND NO ROOT CAUSE COULD BE ESTABLISHED DUE TO MANUFACTURING PROCESSES OR HANDLING BY THE SUPPLIER. THE DEVICE IS SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) WHICH STATES: "..UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.". BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE FAILURE IS MOST LIKELY MANUFACTURING RELATED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INNER STYLET WAS JAMMED IN THE COAXIAL NEEDLE FROM A QUICK-CORE COAXIAL BIOPSY NEEDLE SET BEFORE A LUNG BIOPSY PROCEDURE. THE CANNULA WAS FOUND NOT TO SEPARATE FROM THE NEEDLE PRIOR TO THE PROCEDURE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER QUICK-CORE COAXIAL BIOPSY NEEDLE SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51414 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 8461035 00827002270169

    Patients

    Seq Age Sex Outcome Treatment
    1