BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 7312942 · Received March 5, 2018

    Report

    Report Number
    1820334-2018-00428
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    January 25, 2018
    Report Date
    April 13, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002270176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU) MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA OF THE DEVICE WAS 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. MANUFACTURING DOCUMENTATION WAS REVIEWED AND CONFIRMED THAT STEPS ARE IN PLACE TO ENSURE EACH DEVICE IS INSPECTED FOR MATERIAL UNIFORMITY AND FIT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE IS INCONCLUSIVE WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS PREVIOUSLY SUBMITTED, UNKNOWN, OR UNAVAILABLE ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU) MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA OF THE DEVICE WAS 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. MANUFACTURING DOCUMENTATION WAS REVIEWED AND CONFIRMED THAT STEPS ARE IN PLACE TO ENSURE EACH DEVICE IS INSPECTED FOR MATERIAL UNIFORMITY AND FIT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE IS INCONCLUSIVE WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN OPERATING THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET, THE OPERATOR EXPERIENCED DIFFICULTY UNDOING THE STYLET OF THE DEVICE. THE USER HAD INTRODUCED THE NEEDLE AND GUIDED IT INTO POSITION FOR A BIOPSY UNDER COMPUTED TOMOGRAPHY IMAGING. WHEN THE USER ATTEMPTED TO REMOVE THE STYLET FROM THE NEEDLE TO PERFORM THE BIOPSY, THE STYLET WAS STUCK. THE USER WAS EVENTUALLY ABLE TO UNDO THE STYLET WITH THE HELP OF ARTERY FORCEPS, WHICH WERE GRIPPED FIRMLY TO ASSIST IN THE REMOVAL OF THE STYLET. THE CUSTOMER CONFIRMED THAT THE PRODUCT PROBLEM DID NOT NECESSITATE ANY ADDITIONAL PROCEDURES, AND NO PATIENT ADVERSE EVENTS RESULTED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION. AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT FOR CLARIFICATION OF THE DEVICE COMPONENT RELATED TO THE EVENT, IT SHOULD BE NOTED THAT PER THE CUSTOMER: 16G / 5CM INTRODUCER - WAS THE ISSUE. 18G / 9CM BIOPSY NEEDLE.

    Additional Manufacturer Narrative · 1

    THE 510K #: K973565. (B)(4). 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

    THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN OPERATING THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET, THE OPERATOR EXPERIENCED DIFFICULTY UNDOING THE STYLET OF THE DEVICE. THE USER HAD INTRODUCED THE NEEDLE AND GUIDED IT INTO POSITION FOR A BIOPSY UNDER COMPUTED TOMOGRAPHY IMAGING. WHEN THE USER ATTEMPTED TO REMOVE THE STYLET FROM THE NEEDLE TO PERFORM THE BIOPSY, THE STYLET WAS STUCK. THE USER WAS EVENTUALLY ABLE TO UNDO THE STYLET WITH THE HELP OF ARTERY FORCEPS, WHICH WERE GRIPPED FIRMLY TO ASSIST IN THE REMOVAL OF THE STYLET. THE CUSTOMER CONFIRMED THAT THE PRODUCT PROBLEM DID NOT NECESSITATE ANY ADDITIONAL PROCEDURES, AND NO PATIENT ADVERSE EVENTS RESULTED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158585 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002270176

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR