BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 8065330 · Received November 13, 2018

    Report

    Report Number
    1820334-2018-03375
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 29, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002482951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 9111209. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE CLOSED POSITION. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE COLLET KNOB IS TIGHT AND SECURE. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3.5 CM IN LENGTH. FUNCTIONAL TESTING DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION TO THE OPENED AND CLOSED POSITIONS. VISUAL EXAMINATION NOTED A KINK IN THE BASKET SHEATH 7 CM FROM DISTAL TIP. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9111209. 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 COMPLAINT DEVICE WAS FOUND TO HAVE A BASKET THAT WOULD FULLY OPEN AND CLOSE. NO ISSUES WITH THE FUNCTIONING OF THE BASKET WERE FOUND. THE SHEATH WAS KINKED NEAR THE DISTAL TIP. THE CAUSE FOR THE FAILURE OF THE BASKET TO OPEN WHEN TESTED BY THE CUSTOMER COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THE DEVICE SHEATH WAS IN AN ABNORMAL ORIENTATION THAT, ALONG WITH THE KINKED SHEATH, PREVENTED THE BASKET THE OPENING. A DEFINITIVE CAUSE OF THE REPORTED FAILURE TO OPEN COULD NOT BE ESTABLISHED. 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

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510K # 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 REPORTED, THE USER OPENED THE PACKAGE AND CHECKED THE INTEGRITY OF THE NGAGE NITINOL STONE EXTRACTOR AND FOUND OUT THE BASKET CANNOT BE OPENED. DEVICE WAS NOT USED ON PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903192 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 9111209 00827002482951

    Patients

    Seq Age Sex Outcome Treatment
    1