BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 9536116 · Received December 31, 2019

    Report

    Report Number
    1820334-2019-03180
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 28, 2020
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. CLINIQUE DES CEDRES INFORMED COOK ON 12/17/2019 OF AN INCIDENT INVOLVING A NGAGE NITINOL STONE EXTRACTOR NGE-022115 FROM LOT # 9942725. THE DEVICE REPORTEDLY WOULD NOT OPEN DURING A FLEXIBLE URETEROSCOPY PROCEDURE ON (B)(6) 2019. A SECOND NGAGE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED NO ADDITIONAL HARM AS A RESULT OF THE ISSUE. 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, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE RETURNED DEVICE NOTED THE DEVICE WAS RETURNED WITH THE HANDLE AND BASKET FORMATION IN THE CLOSED POSITION. THE MLLA (MALE LUER LOCK ADAPTER) AND COLLET KNOB WERE TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURED 3.5 CM. NO KINKS WERE NOTED IN THE BASKET SHEATH. TWO OF THE BASKET WIRES OF THE BASKET FORMATION WERE FOUND TO BE BROKEN. IT WAS NOTED THE CLEAR SHEATH WAS SEPARATED. THE DEVICE WAS FOUND TO BE MANUFACTURED TO SPECIFICATION. FUNCTIONAL TESTING FOUND THAT THE HANDLE MOVES, BUT IT DOES NOT ACTUATE THE BASKET FORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. IMPORTANT: ENCLOSE DEVICE IN SHEATH BEFORE REMOVING FROM TRAY/HOLDER. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. STORE IN A DARK, COOL, DRY PLACE. 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. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT WAS CLOSED AND COULD NOT BE OPENED. THE DEVICE WAS DAMAGED IN THE AREA OF THE PROXIMAL END OF THE BASKET. THE BASKET SHEATH HAD THE CLEAR OUTER SHEATH DAMAGED, AND TWO OF THE BASKET WIRES WERE BROKEN IN THE SAME LOCATION. THE PROVIDED INFORMATION STATED THE BASKET FUNCTIONED PROPERLY FOR THE REMOVAL OF ONE STONE BUT WOULD NOT OPEN TO REMOVE THE SECOND STONE. IT APPEARS THE DEVICE WAS DAMAGE BETWEEN THE REMOVAL OF THE FIRST STONE AND THE ATTEMPT TO REMOVE THE SECOND. COOK COULD NOT DETERMINE THE CAUSE FOR THE DAMAGE. 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

    NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: FLEXIBLE SCOPE, IRRIGATION LINE, ACCESS SHEATH, NITINOL WIRE GUIDE. PMA/510K #: EXEMPT. 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, DURING A FLEXIBLE URETEROSCOPY PROCEDURE USING A NGAGE NITINOL STONE EXTRACTOR, THE EXTRACTOR FAILED TO OPEN. THE DEVICE GRASPED A STONE, BUT WHEN THE SURGEON OPENED THE EXTRACTOR TO RETRIEVE THE SECOND STONE, THE DEVICE DID NOT OPEN. THE CAGE REMAINED IN THE SHEATH. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY AS NO SECTION OF THE DEVICE SEPARATED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328871 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48297 9942725 00827002482975

    Patients

    Seq Age Sex Outcome Treatment
    1