BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 9592853 · Received January 15, 2020

    Report

    Report Number
    1820334-2020-00125
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    October 31, 2019
    Report Date
    April 1, 2020
    Manufacturer
    COOK INC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE COAXIAL NEEDLE ASSEMBLY WITHIN A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO UNSCREW. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THE DEVICE DID NOT MAKE PATIENT CONTACT. COOK BECAME AWARE OF THIS EVENT UPON BEING NOTIFIED BY AN AGENT FROM (B)(6) 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 QCS SET WAS RETURNED, CONSISTING OF A COAXIAL NEEDLE SUBASSEMBLY (DTN) AND A BIOPSY NEEDLE (QC). NO DAMAGE WAS NOTED ON EITHER DEVICE. THE DTN WAS RETURNED AS ONE PIECE (SCREWED TOGETHER). THE INNER STYLET AND OUTER CANNULA WERE ABLE TO UNSCREWED BY HAND WITHOUT DIFFICULTY. THE TWO PIECES WERE RETIGHTENED BY HAND, BUT THE FAILURE COULD NOT BE REPLICATED. DIMENSIONS SUCH AS THE STYLET OUTER DIAMETER AND CANNULA INNER DIAMETER WERE MEASURED WITHIN SPECIFICATION. NO ISSUES WERE NOTED ON THE BIOPSY NEEDLE. 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. COOK COULD NOT REVIEW THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. REVIEW OF THE SALES RECORDS TO THE USER FACILITY OVER THREE YEARS PRIOR TO THE DATE OF EVENT COULD NOT SUFFICIENTLY NARROW DOWN THE LOT NUMBER. SINCE POTENTIAL NONCONFORMANCES OR COMPLAINTS FOR THE COMPLAINT LOT COULD NOT BE REVIEWED, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR 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 POTENTIAL CAUSE OF FAILURE CANNOT BE CONFIRMED SINCE THE RETURNED COMPLAINT DEVICE WAS ABLE TO BE UNSCREWED BY HAND WITHOUT DIFFICULTY. 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 MAIN CONTRIBUTING CAUSE OF FAILURE 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.

    Additional Manufacturer Narrative · 1

    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 AN UNKNOWN PATIENT REQUIRED THE USE OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET DURING AN UNKNOWN PROCEDURE. THE OPERATOR REPORTED THAT PRIOR TO PATIENT CONTACT, "THE COAXIAL NEEDLE ASSEMBLY (DTN) WAS DIFFICULT TO UNSCREW, SO THE COAXIAL NEEDLE ASSEMBLY WITHIN THE SET COULD NOT BE SEPARATED." 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
    53728 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1