MAUDE Adverse Event Report: COOK INCORPORATED UNIVERSA; STENT, URETERAL

Model Number	G49977
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
6fr cook medical stent- tear in the stent.

• Brand Name: UNIVERSA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 24363961
• Report Number: 24363961
• Device Sequence Number: 12072170
• Product Code: FAD
• UDI-Device Identifier: 10827002499772
• UDI-Public: 10827002499772
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/05/2026
• Report Date (Section F): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G49977
• Device Catalogue Number: USH-600-R
• Device Lot Number: 16868404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Date Report Sent to FDA: 02/05/2026