BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 9119028 · Received September 25, 2019

    Report

    Report Number
    1820334-2019-02409
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 24, 2019
    Report Date
    February 26, 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

    TWO LOT NUMBERS WERE ORIGINALLY REPORTED. CORRECT LOT NUMBER CLARIFIED AS LOT # 9595295. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: 02OCT2019. INVESTIGATION-EVALUATION: IT WAS REPORTED THAT THE INNER STYLET COULD NOT BE PULLED OUT OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THE DEVICE DID NOT MAKE PATIENT CONTACT. COOK BECAME AWARE OF THIS EVENT ON UPON BEING NOTIFIED BY NANJING CHANGDE MED. SUPP. CO. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, 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. ONE OPENED COAXIAL NEEDLE SUBASSEMBLY (DTN) AND ONE UNOPENED BIOPSY NEEDLE WERE RETURNED. THE DTN SHOWED NO VISIBLE DAMAGE OR BIOLOGICAL MATTER ON THE SURFACE. THE TROCAR STYLET WAS ABLE TO BE UNSCREWED FROM THE NEEDLE CANNULA BY HAND WITHOUT DIFFICULTY. RETIGHTENING THE DTN DOES NOT REPLICATE THE FAILURE MODE. DIMENSIONS SUCH AS STYLET OUTER DIAMETER AND CANNULA 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. ALTHOUGH INSPECTION STEPS ARE IN PLACE RELATED TO THIS FAILURE MODE, A PROJECT WAS OPENED TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR FOR THE FINAL LOT AND RELATED COAXIAL NEEDLE SUBASSEMBLY LOT REVEALED NO RELATED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM 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 WAS SCREWED TOO TIGHTLY DURING QUALITY CONTROL, BUT THIS CANNOT BE DEFINITIVELY CONFIRMED SINCE THE FAILURE MODE COULD NOT BE REPLICATED ON THE RETURNED COMPLAINT DEVICE. ANOTHER UNKNOWN FACTOR MAY BE CONTRIBUTING TO THE DTN BECOMING UNABLE TO BE UNSCREWED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. 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.

    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

    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 AN UNKNOWN PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR AN UNKNOWN PROCEDURE. PRIOR TO PATIENT CONTACT, THE OPERATOR NOTICED "THE INNER STYLET COULDN'T BE PULLED OUT." 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
    912255 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 9595295 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1