BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 22282633 · Received June 18, 2025

    Report

    Report Number
    1820334-2025-00725
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 28, 2025
    Report Date
    April 8, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 (PRIMARY UDI NUMBER). INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THE STENT PORTION OF A BANDER URETERAL DIVERSION STENT SET WAS FOUND TO BE DISCONNECTED UPON OPENING THE PACKAGE PRIOR TO USE IN A URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR STONE REMOVAL. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE 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. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE STENT WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, THE STENT WAS NOTED TO BE SEPARATED FROM THE FIRST INK MARK PAST THE PIGTAIL. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RECORDED DISCREPANCIES RELEVANT TO THE FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS FOUND NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: HOW SUPPLIED ¿UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    D2B - PROCODE: LIE E1 - ADDRESS 2: (B)(6), E1 - PHONE NUMBER: (B)(6). H3: DEVICE EVALUATION IS 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE STENT PORTION OF A BANDER URETERAL DIVERSION STENT SET WAS FOUND TO BE DISCONNECTED UPON OPENING THE PACKAGE PRIOR TO USE IN A URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR STONE REMOVAL. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382833 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL; CATHETER, NEPHROSTOMY FAD COOK INC G14779 16369770 00827002147799

    Patients

    Seq Age Sex Outcome Treatment
    1