BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 6893720 · Received September 26, 2017

    Report

    Report Number
    1820334-2017-03227
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 11, 2017
    Report Date
    December 8, 2017
    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 · 1

    THE 510K CLEARANCE #: K973565. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: MANUFACTURING DATE & EXPIRATION DATE. ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WAS RETURNED FOR EVALUATION. THE COAXIAL NEEDLE ASSEMBLY (TROCAR NEEDLE STYLET AND AN OUTER CANNULA) WAS OPENED BUT THE BIOPSY NEEDLE WAS UNOPENED AND SEALED. THE TROCAR NEEDLE STYLET WAS LOCKED INTO THE OUTER CANNULA. FUNCTIONAL TESTING OF THE COMPONENTS IN QUESTION WAS PERFORMED IN WHICH THE INVESTIGATOR ATTEMPTED TO UNLOCK THE HUB AND REMOVE THE STYLET FROM THE OUTER CANNULA. DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO TWIST AND UNSCREW THE HUB OF THE NEEDLE STYLET FROM THE OUTER CANNULA. AS A RESULT, THE INVESTIGATOR WAS UNABLE TO UNLOCK THE CONNECTION, EVEN WITH EXCESSIVE FORCE APPLIED TO THE HUB. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. VERIFICATION OF THE FIT BETWEEN THE STYLET AND CANNULA, AND FINAL INSPECTION OF THE ASSEMBLY IS PERFORMED PRIOR TO SHIPPING. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. IT IS POSSIBLE THAT DURING THE ASSEMBLY/MANUFACTURING PROCESS, TOO MUCH FORCE WAS APPLIED TO THE HUB OF THE TROCAR NEEDLE STYLET WHEN ATTACHING WITH THE NEEDLE CANNULA. THIS WOULD CAUSE AN OVER-TIGHTENING OF THE NEEDLE STYLET HUB TO THE CANNULA'S LUER LOCKING HUB AND MAKE REMOVAL OF THE NEEDLE STYLET DIFFICULT. ADDITIONALLY, HUMIDITY FROM THE ATMOSPHERE CAN CAUSE THE KNOBS TO SWELL DUE TO THE HYGROSCOPIC PROPERTIES OF THE COMPONENT MATERIAL. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE FOR THIS EVENT IS RELATED TO MANUFACTURING OF THE DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, AT AN UNSPECIFIED POINT IN TIME, A QUICK-CORE COAXIAL BIOPSY NEEDLE COULD NOT PULL OUT FROM THE CANNULA THAT WAS INCLUDED IN THE SET. THE CUSTOMER DID CONFIRM THAT THE ISSUE WITH THE PRODUCT WAS DISCOVERED PRIOR TO PATIENT CONTACT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS WERE REPORTED. THE CONDITIONS SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE ALSO NOT REPORTED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674356 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1