BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 9538428 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00026
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 28, 2020
    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 · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON RECEIVING ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE FAILURE MODE, THIS EVENT IS NOT REPORTABLE. IT WAS PREVIOUSLY THOUGHT THE DTN COULD NOT UNSCREW, BUT THE CUSTOMER CONFIRMED THIS IS NOT THE CASE. INSTEAD, THE ISSUE WAS THAT THE QC NEEDLE EXPERIENCED FIRING ISSUES. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE COMPLAINT EVENT, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 20FEB2020 INDICATING THE FAILURE WAS NOT THAT THE DTN COULD NOT UNSCREW, BUT THAT THE QC NEEDLE COULD NOT "SPRING BACK."

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. 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 AN UNKNOWN PATIENT REQUIRED THE USE OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR A LUNG BIOPSY. PRIOR TO PATIENT CONTACT, THE OPERATOR "FOUND THE NEEDLE COULD NOT WITHDRAW FROM OUTER CATHETER." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER, SIMILAR DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 9812197 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1