BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 7248145 · Received February 7, 2018

    Report

    Report Number
    1820334-2018-00234
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 17, 2018
    Report Date
    April 9, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    510K #: K973565 (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION/FUNCTIONAL TEST OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE CONFIRMS WE RECEIVED ONE NEEDLE WITH NEEDLE PROTECTOR. NO DAMAGE TO THE DEVICE WAS NOTED. UPON REMOVAL OF THE STYLET, BIOMATTER WAS NOTICED ON THE EXTERIOR OF THE STYLET INDICATING THE DEVICE WAS LIKELY USED. THE TRANSITION OF THE STYLET WITHIN THE HUB AND CANNULA WAS TESTED. LOOSENING THE HUB TO RELEASE THE STYLET WAS VERY DIFFICULT AND REQUIRED A SIGNIFICANT AMOUNT OF FORCE. HOWEVER, THE STYLET WAS SUCCESSFULLY RELEASED AND NO TIGHTNESS OR DRAGGING WAS NOTED BETWEEN THE STYLET AND THE CANNULA. 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 NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THEREFORE THERE IS NO EVIDENCE TO SUGGEST NON-CONFORMING PRODUCT IN HOUSE OR IN THE FIELD. MANUFACTURING DOCUMENTATION WAS REVIEWED AND CONFIRMED THAT STEPS ARE IN PLACE TO ENSURE EACH DEVICE IS CHECKED FOR SMOOTH TRANSITION BETWEEN PARTS. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE STYLET PORTION OF THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET COULD NOT BE REMOVED FROM THE INTRODUCER NEEDLE. THE NEEDLE HAD BEEN GUIDED INTO POSITION FOR THE INTENDED BIOPSY OF THE MASS UNDER COMPUTED TOMOGRAPHY IMAGING. THE PRODUCT PROBLEM ULTIMATELY NECESSITATED THE REMOVAL OF THE ENTIRE NEEDLE/STYLET ASSEMBLY, AND THE USE OF A NEW INTRODUCER NEEDLE FROM A DIFFERENT PRODUCT. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE REQUIRED. THE COMPLAINT DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93759 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR