BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 7540015 · Received May 24, 2018

    Report

    Report Number
    1820334-2018-01529
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    May 14, 2018
    Report Date
    February 6, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087903
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THREE UNOPENED, UNUSED DEVICES WERE RETURNED IN ADDITION TO THE TWO DEVICES PREVIOUSLY REPORTED. THE THREE UNOPENED, UNUSED DEVICES WERE BENCH-TESTED BY THE MANUFACTURER AND DETERMINED TO SHARE THE SAME FAILURE MODE AS THE PREVIOUSLY REPORTED DEVICES. D10 ¿ PRODUCT RECEIVED ON: 29MAY2018. INVESTIGATION ¿ EVALUATION. A REVIEW OF DEVICE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTION FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROLS, AND TRENDS WERE CONDUCTED DURING THE COURSE OF THE INVESTIGATION. IN ADDITION, A DIMENSIONAL VERIFICATION, A FUNCTIONAL TEST, AND A VISUAL INSPECTION WAS CONDUCTED ON THE COMPLAINTS DEVICES. THREE UNOPENED AND UNUSED DEVICES WERE RETURNED BY THE CUSTOMER FROM THE SAME LOT. THESE UNUSED SAMPLES WERE ALSO INSPECTED FIVE DEVICES IN TOTAL WERE RETURNED BY THE CUSTOMER CONSISTING OF ONE USED, ONE OPENED BUT UNUSED, AND THREE UNOPENED DEVICES. PHYSICAL EXAMINATION OF THESE DEVICES REVEALED THAT ALL THE RETURNED DEVICES EXHIBITED DIFFICULTY IN SEPARATING THE STYLET FROM THE CANNULA. TESTING DURING THE INVESTIGATION DETERMINED THAT EXCESSIVE FORCE WAS NECESSARY TO SEPARATE THE CANNULA FROM THE NEEDLE. ALL DEVICES WERE MEASURED TO BE WITHIN SPECIFICATION FOR THE STYLET OUTER DIAMETER, CANNULA INNER DIAMETER, AND GRIT BLAST LENGTH. A REVIEW OF THE DESIGN HISTORY FILE WAS CONDUCTED FOR THE COMPLAINT DEVICE. IT WAS DETERMINED THAT THERE IS NO DESIGN VERIFICATION TESTING OR DESIGN/PROCESS VALIDATION TESTING RELEVANT TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THE OBSERVED DIFFICULTY EXPERIENCES DURING THESE DEVICE TESTS IS A RESULT OF REASSEMBLY OF THE DEVICE FOLLOWING QUALITY CONTROL ACTIVITIES. THE DEVICE HISTORY RECORD OF LOT 8451147 SHOWED ONE NONCONFORMANCE WHERE ONE DEVICE WAS REWORKED FOR FOREIGN MATTER ON BOTH INNER PACKAGE SEALS. A LOT REVIEW FOUND NO ADDITIONAL NONCONFORMANCES IN HOUSE OR IN THE FIELD. AS A RESULT OF OUR INVESTIGATION, EXAMINATION OF THE RETURNED DEVICES, AND THE INFORMATION AVAILABLE, THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. MEASURES ARE BEING TAKEN TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PEOPLE HAVE BEEN NOTIFIED. 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 INFORMATION HAS BEEN ADDED TO THE DESCRIPTION OF EVENT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PATIENT CODE: NO CODE AVAILABLE- THE PROCEDURE WAS ABORTED. DEVICE CODE: DEVICE OPERATES DIFFERENTLY THAN EXPECTED. 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 USED FOR A LUNG BIOPSY BY A CT-GUIDED PERCUTANEOUS PARCENTESIS. AFTER THE DEVICE WAS ADVANCED TO THE BORDER OF THE LESION, THE USER WENT TO RETRACT THE STYLET AND COULD NOT PULL IT OUT FROM THE CANNULA. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS INSERTED. THIS SECOND DEVICE OF THE SAME LOT EXHIBITED THE SAME ISSUE. AS REPORTED, THE PROCEDURE WAS ABORTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382188 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention