BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 25277837 · Received May 26, 2026

    Report

    Report Number
    1820334-2026-00543
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 26, 2026
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002147799
    PMA / PMN Number
    K181971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: LJE CATHETER, NEPHROSTOMY. D2B - PRODUCT CODE: ADDITIONAL PRODUCT CODES: LJE. E1 - PHONE NUMBER: (B)(6). H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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 DURING USE OF THE BANDER URETERAL DIVERSION STENT SET, THE STENT WAS OBSERVED TO HAVE BROKEN. THE DEVICE FRACTURED WITH ONLY SLIGHT TRACTION. NO PORTION OF THE STENT REMAINED INSIDE THE PATIENT. THE USER REPLACED IT WITH A NEW BANDER URETERAL DIVERSION STENT SET AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7269 BANDER URETERAL DIVERSION STENT SET FAD; STENT, URETERAL FAD COOK INC G14779 16943015 00827002147799

    Patients

    Seq Age Sex Outcome Treatment
    1