BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 8790655 · Received July 15, 2019

    Report

    Report Number
    1820334-2019-01690
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    July 8, 2019
    Report Date
    January 28, 2020
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002270169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 ¿ CONCOMITANT MEDICAL PRODUCT RECEIVED ON: 06AUG2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST AND ,DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED WITHOUT ANY NOTABLE DAMAGE OR BIOLOGICAL MATTER ON THE SURFACE. THE COAXIAL NEEDLE ASSEMBLY (DTN) COULD NOT BE UNSCREWED BY HAND, BUT COULD BE UNSCREWED USING PLIERS. THE FAILURE WAS ABLE TO BE REPLICATED BY RETIGHTENING THE DTN. DIMENSIONS SUCH AS STYLET OUTER DIAMETER AND CANNULA INNER DIAMETER WERE MEASURED WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT SHOWED NO RELEVANT NONCONFORMANCES. ADDITIONALLY THE COAXIAL NEEDLE SUBASSEMBLY LOT SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM THE COMPLAINT LOT AT THE TIME OF INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) ARE PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: INTENDED USE: QUICK-CORE BIOPSY NEEDLES ARE INTENDED FOR SOFT TISSUE BIOPSY. THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR SOFT TISSUE BIOPSY SHOULD BE EMPLOYED. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. IT IS POSSIBLE THAT THE DEVICE WAS SCREWED TOO TIGHTLY DURING QUALITY CONTROL, BUT THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONTACT INFORMATION: POSTAL CODE: (B)(6). INITIAL REPORTER OCCUPATION: UNKNOWN. PMA/510(K) #: K973565. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS TO BE USED ON A FEMALE PATIENT FOR A BREAST AND LUNG BIOPSY. PRIOR TO PATIENT CONTACT, IT WAS REPORTED THE COAXIAL NEEDLE WAS JAMMED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584679 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 9378629 00827002270169

    Patients

    Seq Age Sex Outcome Treatment
    1