MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD; STENT, URETERAL

Model Number	G16997
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a: catheter, nephrostomy.D2b: lje.E1 - title: bsn, rn, ms, cnor nurse manager.H3 ¿ the device return is unknown.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.
Event or Problem Description
It was reported that, during the procedure of ureteral stent removal, a bander ureteral diversion stent set fractured while being removed.The patient had a previously placed ureteral stent, leaving a retained fragment stent within the urinary tract.The retained fragment could not be retrieved using standard cystoscopic techniques.As a result of this device failure, the patient will require an additional operative intervention.A percutaneous nephrolithotomy (pcnl)-type procedure with percutaneous renal access will be necessary to retrieve the retained stent fragment.No other adverse effects were reported for this incident.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Common Device Name: FAD; STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 25752053
• Report Number: 1820334-2026-00722
• Device Sequence Number: 10242908
• Product Code: FAD
• UDI-Device Identifier: 00827002169975
• UDI-Public: (01)00827002169975(17)260817(10)15614127
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: G16997
• Device Catalogue Number: 025226
• Device Lot Number: 15614127
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown