BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 6914357 · Received October 4, 2017

    Report

    Report Number
    1820334-2017-03481
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 6, 2017
    Report Date
    November 2, 2017
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE ACTUAL DEVICE AND DIMENSIONAL VERIFICATION WAS COMPLETED DURING THIS INVESTIGATION. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND IT WAS FOUND THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE FAILURE MODE OF INCOMPATIBILITY BETWEEN THE STYLET AND THE CANNULA AND IDENTIFIES THAT MULTIPLE RISK CONTROLS ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND. A COMPLAINT HISTORY SEARCH REVEALED THIS TO BE THE ONLY COMPLAINT REPORTED FOR ASSOCIATED LOTS AT THE TIME OF INVESTIGATION. AN OPENED, UNUSED PRODUCT WAS RETURNED. MEASUREMENTS OF THE NEEDLE AND CANNULA WERE PERFORMED AND IT WAS FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. WITH THE PROVIDED INFORMATION, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. A QUALITY ENGINEERING RISK ASSESSMENT DETERMINED THAT NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    THE 510K # - 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.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, PRIOR TO PATIENT CONTACT, THE NEEDLE IN THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET WOULD NOT PULL OUT OF THE CANNULA. THE OPERATOR EMPLOYED ANOTHER NEW DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY, WITH NOT FURTHER COMPLICATIONS REPORTED. THE CUSTOMER CONFIRMED THAT NO ADVERSE EFFECTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE PRODUCT WAS RECEIVED 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
    693064 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002087286

    Patients

    Seq Age Sex Outcome Treatment
    1