BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 7922819 · Received October 1, 2018

    Report

    Report Number
    1820334-2018-02831
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    August 14, 2018
    Report Date
    November 13, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS COMPLAINT DEVICE LOT NUMBER 8762472. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE CLOSED POSITION AND THE BASKET FORMATION PARTIALLY OPEN. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.8 CM IN LENGTH. VISUAL EXAMINATION NOTES THE SUPPORT SHEATH IS CRACKED 2 CM FROM THE DISTAL TIP OF THE SUPPORT SHEATH. THERE IS A KINK IN THE BASKET SHEATH LOCATED 88.5 CM FROM DISTAL TIP AND A KINK 2.3 CM FROM THE DISTAL TIP OF THE SUPPORT SHEATH. FUNCTIONAL TESTING DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION TO THE OPEN POSITION, BUT IT DOES NOT FULLY CLOSE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THIS REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8762472. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND DAMAGE PRIOR TO PACKAGING AND ARE PACKAGED WITH THE BASKET OPEN. THE IFU CONTAINS CAUTIONS ABOUT MANIPULATING THE DEVICE TO PREVENT DAMAGE. THE SHEATH DAMAGE PREVENTED THE BASKET FROM FUNCTIONING NORMALLY. IT IS LIKELY THE SHEATH OF THE DEVICE WAS INADVERTENTLY DAMAGED DURING HANDLING/USE OF THE DEVICE. THE INVESTIGATION CONCLUSION IS CAUSE TRACED TO USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # - EXEMPT. (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

    IT WAS INITIALLY REPORTED THE NGAGE NITINOL STONE EXTRACTOR BASKET DOES NOT CLOSE PROPERLY. NEW MEDICAL DEVICE WAS USED. PATIENT OUTCOME: NONE. ADDITIONAL INFORMATION WAS RECEIVED ON 28SEP2018. IT WAS REPORTED DURING A FLEXIBLE URETEROSCOPY PROCEDURE IN THE KIDNEY, THE NGAGE NITINOL STONE EXTRACTOR BASKET DID NOT CLOSE PROPERLY. THE SURGEON USED A NEW PRODUCT TO COMPLETE THE PROCEDURE. NO INTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763867 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 8762472 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1 NITINOL WIRE GUIDE, CATHETER, FLEXIBLE SCOPE