BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 8623460 · Received May 20, 2019

    Report

    Report Number
    1820334-2019-01160
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 25, 2019
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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 COMPLETED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED ONE DEVICE FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED LOT NUMBER. THE DEVICE WAS RETURNED WITH THE HANDLE AND BASKET FORMATION IN THE OPEN POSITION. VISUAL EXAMINATION NOTED NO KINKS IN THE BASKET SHEATH. FUNCTIONAL TESTING DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION SMOOTHLY. THE RETURNED DEVICE FUNCTIONS AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE ARE NO NON-CONFORMANCES. NO OTHER COMPLAINTS ARE ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING RELEVANT INFORMATION TO THE USER. PRECAUTION: ENCLOSE THE DEVICE IN THE SHEATH BEFORE REMOVING FROM THE TRAY/HOLDER. PRECAUTION: DO NOT USE EXCESSIVE FORCE TO MANIPULATE THIS DEVICE. DAMAGE TO THE DEVICE MAY OCCUR. THE RETURNED DEVICE FUNCTIONED AS INTENDED. THE CUSTOMER¿S DIFFICULTY COULD NOT BE RECREATED DURING THE INVESTIGATION. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE RETURNED DEVICE WAS FOUND TO BE FUNCTIONAL, WITH THE BASKET OPENING AND CLOSING WHEN THE HANDLE WAS FUNCTIONED. THERE WAS NO DAMAGE TO THE DEVICE. THE COMPLAINT COULD NOT BE CONFIRMED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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 EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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

    WHEN THE PHYSICIAN WENT TO USE THE NTSE-015115 TO GRAB A SALIVARY STONE, HE TRIED TO OPEN AND CLOSE BASKET BEFORE ENTERING INTO THE PATIENT'S BODY. HE FOUND THE EXTRACTOR CANNOT OPEN AND CLOSE SMOOTHLY. THEN HE USED A DIFFERENT METHOD TO GRAB THE STONE. THE PATIENT OUTCOME WAS GOOD. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): DEVICE DESCRIPTION THE NCIRCLE, NCOMPASS, AND NFORCE STONE EXTRACTORS ARE 3- OR 4-WIRE NITINOL BASKETS AVAILABLE IN A RANGE OF FRENCH SIZES, LENGTHS, AND BASKET DIAMETERS. INTENDED USE: THE NCIRCLE, NCOMPASS, AND NFORCE STONE EXTRACTORS ARE INTENDED FOR STONE MANIPULATION AND REMOVAL IN THE URINARY TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418498 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G46206 9278930 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR SALIVARY SCOPE| SALIVARY SCOPE