BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 20396219 · Received October 8, 2024

    Report

    Report Number
    1820334-2024-01310
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 25, 2024
    Report Date
    September 18, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002147796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A, 2B.- COMMON DEVICE NAME, PROCODE: FAD STENT, URETERAL; LJE CATHETER, NEPHROSTOMY. E1 - NAME AND ADDRESS: (B)(6). E3- OCCUPATION: AGENT. G4- PMA/510(K) #: K181971. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING AN URETERAL DIVERSION PROCEDURE, THE USER CHECKED THE OUTER PACKAGING OF A BANDER URETERAL DIVERSION STENT SET AND FOUND IT TO BE INTACT BEFORE THE OPERATION. HOWEVER, AFTER OPENING THE PACKAGING, IT WAS FOUND THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING DOCUMENTS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE STENT WAS ALMOST COMPLETELY SEPARATED 62.3CM FROM THE DISTAL TIP. THE POINT OF DAMAGE IS CLEAN AND EVEN. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND ONE ADDITIONAL COMPLAINT FOR THIS LOT NUMBER. THE PRODUCT IFU STATES, ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN URETERAL DIVERSION PROCEDURE, THE USER CHECKED THE OUTER PACKAGING OF A BANDER URETERAL DIVERSION STENT SET AND FOUND IT TO BE INTACT BEFORE THE OPERATION. HOWEVER, AFTER OPENING THE PACKAGING, IT WAS FOUND THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544252 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC G14779 16030101 10827002147796

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male