BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 12529534 · Received September 24, 2021

    Report

    Report Number
    1820334-2021-02221
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 30, 2021
    Report Date
    June 2, 2022
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087903
    PMA / PMN Number
    K973565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. (B)(6) HOSPITAL OF HENAN PROVINCE INFORMED COOK OF AN ISSUE WITH A STYLET FROM A QCS-18-15.0-20T (QUICK-CORE COAXIAL BIOPSY NEEDLE SET) FROM LOT 13736369. THE STYLET WAS SCREWED TOO TIGHT IN THE OUTER PART OF THE NEEDLE AND COULD NOT BE TAKEN APART. THE FAILURE WAS NOTICED PRIOR TO USE. NEEDLE HOLDERS WERE USED TO UNSCREW THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THERE ARE APPROPRIATE CONTROLS IN PLACE TO DETECT DAMAGE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS HAD NO NONCONFORMANCES. A DATABASE SEARCH FOUND NO ADDITIONAL COMPLAINTS. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU (T_QC_REV6) ¿QUICK CORE BIOPSY NEEDLES AND SETS¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE DEVICE HISTORY RECORD, DEVICE MASTER RECORD, DESIGN HISTORY FILE, AND PRODUCT LABELING REVIEW, THERE IS NO INDICATION THIS COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING PRODUCTS IN HOUSE OR IN THE FIELD. IT IS POSSIBLE THE DEVICE WAS SCREWED TOO TIGHTLY DURING QUALITY CONTROL, BUT THIS POTENTIAL CAUSE OF FAILURE CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THERE IS NO EVIDENCE OF MANUFACTURING DEFICIENCY. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS COMPONENT FAILURE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER -CUSTOMER (PERSON): PHONE: (B)(6). 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 THAT THE INNER STYLET OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO REMOVE FROM THE COAXIAL NEEDLE. IT WAS ONLY ABLE TO BE UNSCREWED "WITH THE HELP OF THE NEEDLE HOLDER." THIS OCCURRED PRIOR TO PATIENT CONTACT, AND THE PROCEDURE WAS CONTINUED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426324 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 13736369 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown