BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 20951205 · Received December 17, 2024

    Report

    Report Number
    1820334-2024-01652
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 18, 2024
    Report Date
    November 6, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2B. PROCODE: LIE. E1: CUSTOMER POSTAL CODE = 7218511. E3: CUSTOMER OCCUPATION = UNKNOWN. G4 ¿ PMA/510(K) #: K181971. H3: DEVICE HAS BEEN RETURNED, AND PRELIMINARY EVALUATION HAS BEEN PERFORMED, HOWEVER, OUR INVESTIGATION IS ONGOING, AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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 THERE WAS RESISTANCE IN THE BANDER URETERAL DIVERSION STENT SET'S CATHETER WHEN THE PHYSICIAN FLUSHED IT PRIOR TO A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. THE WATER HADN'T COME OUT FROM THE TIP, FOREIGN MATTER IN THE LUMEN WAS SUSPECTED AND DEVICE USE WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239662 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC G57582 16170167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown