MAUDE Adverse Event Report: Cook Inc Ultrathane Cope Nephroureterostomy Set; FAD; Stent, Ureteral

Model Number	G48164
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury

• Brand Name: Ultrathane Cope Nephroureterostomy 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 ; +1(812)339-2235
• MDR Report Key: 50809515
• Report Number: 1820334-2026-00986
• Device Sequence Number: 8900704
• Product Code: FAD
• UDI-Device Identifier: 00827002481640
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K171603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: G48164
• Device Catalogue Number: ULT10.2-10.2-24-NUCL-B-RH
• Device Lot Number: 17127445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2026
• 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