BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 17916512 · Received October 11, 2023

    Report

    Report Number
    1820334-2023-01374
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    October 9, 2023
    Report Date
    March 8, 2024
    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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THE STYLET OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO SEPARATE FROM THE COAXIAL NEEDLE DURING A LUNG BIOPSY FOR AN UNKNOWN PATIENT. BEFORE THE PROCEDURE, THE OUTER PACKAGING OF THE PRODUCT WAS CHECKED, AND NO DAMAGE WAS FOUND. AFTER OPENING THE PACKAGE AND REMOVING THE DEVICE, IT WAS FOUND THAT THE COAXIAL NEEDLE COULD NOT BE UNSCREWED AS NORMAL. THE STYLET WAS NOTED TO BE SCREWED TOO TIGHTLY AND COULD NOT BE SEPARATED FROM THE OUTER PART OF THE NEEDLE. AFTER EXPERIENCING THIS ISSUE WITH FOUR DIFFERENT DEVICES OF THE SAME LOT WITHIN THE SAME PROCEDURE, THE FIFTH DEVICE FUNCTIONED AS INTENDED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. NO ADVERSE EFFECTS HAVE BEEN REPORTED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), 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. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK REVIEWED THE DHR FOR THE REPORTED LOT. NO NONCONFORMANCES OR ADDITIONAL COMPLAINTS WERE FOUND. THE DTN SUBASSEMBLY LOT ALSO SHOWED NO NONCONFORMANCES. BASED ON THE DMR AND DHR THERE IS NO INDICATION THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_QC_REV5] ¿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 INFORMATION PROVIDED, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED A CAUSE COULD NOT BE ESTABLISHED FOR THIS EVENT. IT IS POSSIBLE THAT THE NEEDLES WERE OVER TIGHTENED DURING QC, HOWEVER THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - CUSTOMER (PERSON): PHONE: (B)(6). E3 - OCCUPATION: AGENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: D9, H3 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE STYLET OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO SEPARATE FROM THE COAXIAL NEEDLE DURING A LUNG BIOPSY FOR AN UNKNOWN PATIENT. BEFORE THE PROCEDURE, THE OUTER PACKAGING OF THE PRODUCT WAS CHECKED, AND NO DAMAGE WAS FOUND. AFTER OPENING THE PACKAGE AND REMOVING THE DEVICE, IT WAS FOUND THAT THE COAXIAL NEEDLE COULD NOT BE UNSCREWED AS NORMAL. THE STYLET WAS NOTED TO BE SCREWED TOO TIGHTLY AND COULD NOT BE SEPARATED FROM THE OUTER PART OF THE NEEDLE. AFTER EXPERIENCING THIS ISSUE WITH FOUR DIFFERENT DEVICES OF THE SAME LOT WITHIN THE SAME PROCEDURE, THE FIFTH DEVICE FUNCTIONED AS INTENDED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312143 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 13139537 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown