BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 8855140 · Received August 2, 2019

    Report

    Report Number
    1820334-2019-01916
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 1, 2019
    Report Date
    February 18, 2020
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10- CONCOMITANT MEDICAL PRODUCT RECEIVED ON: 12AUG2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED NO DAMAGE OR BIOLOGICAL MATTER ON EITHER THE BIOPSY NEEDLE (QC) OR THE COAXIAL NEEDLE SUBASSEMBLY (DTN) . THE DTN WAS UNABLE UNSCREWED BY HAND. PLIERS WERE USED TO UNSCREW THE DTN SUCCESSFULLY. SCREWING THE DTN TOGETHER AGAIN REPLICATES THE FAILURE OF DIFFICULTY IN UNSCREWING. 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) WAS REVIEWED. THE COMPLAINT FINAL LOT AND RELEVANT SUBASSEMBLY LOT SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM THE LOT AT THE TIME OF INVESTIGATION. SINCE THERE ARE NO RELATED NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE 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 IS SCREWED TOO TIGHTLY DURING PERTINENT QUALITY CONTROL INSPECTION STEPS, BUT THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, NO 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

    (B)(6). OCCUPATION: AGENT. 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 SELECTED TO BE USED FOR AN UNKNOWN PROCEDURE. AS REPORTED, THE OPERATOR "CHECKED THE DEVICE PRIOR TO PROCEDURE AND FOUND THE INNER STYLET COULDN'T BE PULLED OUT FROM THE CANNULA. THE OPERATOR CHANGED TO ANOTHER POUCH TO USE AND FINISHED THE PROCEDURE SUCCESSFULLY." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650362 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 9755610 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1