BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCIRCLE TIPLESS STONE EXTRACTOR

    MDR report key: 6793711 · Received August 15, 2017

    Report

    Report Number
    1820334-2017-02522
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    August 9, 2017
    Report Date
    January 31, 2018
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002462069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION / INVESTIGATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA, AND TRENDS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE CLOSED POSITIONS. A FUNCTIONAL TEST DETERMINED THE HANDLE ACTUATES THE BASKET FORMATION. A VISUAL EXAMINATION OF THE BASKET FORMATION LOOKS FLAT IN APPEARANCE WHEN IN OPEN POSITION. THE KNOT ON THE BASKET FORMATION LOOKS LIKE IT HAS SLIPPED AND NO LONGER INTERLOCKING. 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 DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE TWO NON-CONFORMANCE ISSUES IDENTIFIED DURING MANUFACTURING; HOWEVER, ALL NON-CONFORMING PRODUCT WAS SCRAPPED PRIOR TO FINAL PROCESSING. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED ASSOCIATED WITH LOT NUMBER 7842937. THE RETURNED DEVICE WAS FOUND TO HAVE A DEFORMED BASKET. THE BASKET WAS FOUND TO BE DEFORMED BEFORE USE. ALL DEVICES ARE INSPECTED FOR FUNCTIONALITY AND INTEGRITY BEFORE PACKAGING. IT IS POSSIBLE THAT THE DAMAGE OCCURRED DURING PACKING, SHIPPING, OR HANDLING OF THE DEVICE. BASED ON THE PROVIDED INFORMATION, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE NCIRCLE TIPLESS STONE EXTRACTOR WAS TESTED PRIOR TO USE. THE BASKET WOULD NOT OPEN IN ITS NORMAL SHAPE. WHEN THE BASKET OPENS THE SHAPE IS DEFORMED/SMASHED. THIS DEVICE WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT CONTACT THE PATIENT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574254 NCIRCLE TIPLESS STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 00827002462069

    Patients

    Seq Age Sex Outcome Treatment
    1