BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 7504479 · Received May 10, 2018

    Report

    Report Number
    1820334-2018-01405
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    June 29, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002270176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. NO COMPLAINT DEVICE HAS BEEN RETURNED FOR INVESTIGATION. NO PHOTOS HAVE BEEN PROVIDED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. A DEVICE HISTORY RECORD OF THE LOT WAS REVIEWED AND FOUND NO NON-CONFORMANCES FOR EITHER THE DEVICE OR COMPONENT COAXIAL SUPPORT NEEDLE. A REVIEW OF COMPLAINTS FROM THE SAME LOT WAS CONDUCTED AND FOUND NO REPORTED COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE CUSTOMER HAS BEEN UNRESPONSIVE AND HAS NOT PROVIDED UPDATED INFORMATION ON IF THE DEVICE WILL BE RETURNED. IF THE COMPLAINT DEVICE BECOMES AVAILABLE FOR INVESTIGATION IN THE LAB, THE DEVICE WILL BE EVALUATED AND THE FILE WILL BE UPDATED AT THAT TIME. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, TWO POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED AS MANUFACTURING RELATED (OPERATOR RELATED/PROCESS RELATED). WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME. 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K973565. (B)(4). 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 BEING TESTED DURING PRE-OP AND THE INTRODUCER WAS FAULTY. THE CAP ON THE INTRODUCER WAS UNABLE TO BE UNSCREWED; THEREFORE, THE NEEDLE COULD NOT BE PUT THROUGH. AS REPORTED, THIS OCCURRED PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345150 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC 00827002270176

    Patients

    Seq Age Sex Outcome Treatment
    1