BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 20494664 · Received October 21, 2024

    Report

    Report Number
    1820334-2024-01377
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 20, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002156968
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    . E1: CUSTOMER (PERSON) ADDRESS = (B)(6). E3: CUSTOMER OCCUPATION = UNKNOWN G4: PMA/510(K) NUMBER = K180053. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    IT WAS REPORTED THAT THE 'STRINGS' DETACHED FROM THE 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED PATIENT SELF-REMOVAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, DURING A RIGHT FLEXIBLE URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, AND THE PATIENT ATTEMPTED TO REMOVE THE STENT, AS INSTRUCTED, ON 02JUL2024 . DURING ATTEMPTED REMOVAL, THE 'STRINGS' SEPARATED FROM THE DEVICE AND THE STENT REMAINED IN THE PATIENT. THE PATIENT RETURNED TO THE CLINICAL SETTING ON (B)(6) 2024 AND RETAINED STENT WAS CONFIRMED VIA IMAGING. THE USER ATTEMPTED TO REMOVE THE STENT WITH A FLEXIBLE CYSTOSCOPE BUT WAS UNSUCCESSFUL. THE STENT IS SCHEDULED TO BE RETRIEVED UNDER A GENERAL ANESTHESIA (GA) ON (B)(6) 2024; NO INFORMATION HAS SINCE BEEN MADE AVAILABLE REGARDING THE SCHEDULED STENT REMOVAL. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010803 SOF-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15696 15882777 00827002156968

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention OLYMPUS URF-V3| STORZ CYSTOSCOPE| WOLF UTERENOSCOPE