BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 9686252 · Received February 10, 2020

    Report

    Report Number
    1820334-2020-00316
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 11, 2020
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. COOK WAS INFORMED ON 02/06/2020 OF AN INCIDENT INVOLVING A NGAGE NITINOL STONE EXTRACTOR NGE-017115. THE DEVICE REPORTEDLY WAS UNABLE TO CAPTURE STONES DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE ON (B)(6) 2020. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT AFTER THREE TIMES OF USING THE DEVICE, GRASPING FORCE OF THE BASKET BECAME WEAK AND THE BASKET BECAME UNABLE TO CAPTURE STONES ANYMORE. ANOTHER NGE-017115 DEVICE 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, DRAWING, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL DATA. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THE HANDLE AND BASKET FORMATION WERE IN THE CLOSED POSITION. THE MLLA (MALE LUER LOCK ADAPTER) AND COLLET KNOB WERE TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING [PETT] MEASURED 3.7 CM IN LENGTH. THERE WERE NO KINKS IN THE BASKET SHEATH. THE BASKET WIRES WERE TWISTED. FUNCTIONAL TESTING DETERMINED THE HANDLE DOES NOT ACTUATE THE BASKET FORMATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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 RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER RELATED COMPLAINTS FROM THE LOT 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 WITH DAMAGED WIRES THAT COULD NOT BE FULLY OPENED OR CLOSED. THE PROVIDED INFORMATION STATED THE BASKET FUNCTIONED NORMALLY 3 TIMES, BUT THEN WAS UNABLE TO GRASP STONES. IT WAS CONCLUDED THAT THE DEVICE WAS FUNCTIONING NORMALLY, BUT AFTER THE 3RD STONE WAS REMOVED, THE BASKET OF THE DEVICE BECAME DAMAGED. THE CAUSE FOR THE DAMAGED BASKET COULD NOT BE CONCLUSIVELY DETERMINED BUT COULD HAVE BEEN RELATED TO PROCEDURAL ISSUES SUCH AS THE SIZE, SHAPE, AND/OR LOCATION OF THE STONE(S) IN THE ANATOMY. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL 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 NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 TRANSURETHERAL LITHOTRIPSY (TUL) PROCEDURE USING NGAGE NITINOL STONE EXTRACTOR, THE BASKET WAS UNABLE TO CAPTURE THE STONES. AFTER CONFIRMING THE STONES WERE IN VIEW, THE USER ATTEMPTED THREE TIMES TO CAPTURE THE STONES, BUT THE GRASPING FORCE WAS WEAK AND THEY WERE UNABLE TO. ANOTHER NGE-017715 WAS USED TO COMPLETE THE PROCEDURE INSTEAD. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151776 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 10126628 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death