MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G23406
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: customer occupation: 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 the universa firm ureteral stent set's stents had some sort of whitish film when they remove from the sterilized packaging prior to use in an unknown procedure.Customer provided two videos appearing to show a stent being placed in a basin of clear fluid and then the straightener being used to straighten out the stent pigtails.The video then focuses on the tip of the straightener where a semi translucent material appears to have accumulated.Additional information has been requested but is unavailable at this time.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.As reported, the stent had some sort of whitish film when they removed it from the sterilized packaging prior to use in an unknown procedure.Upon further review, the complaint was assessed under the risk of the stent being discolored due to the way the film caused the device to appear.Therefore, there is no evidence to suggest that the observed device failure, "the device was discolored" would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 21139161
• Report Number: 1820334-2025-00045
• Device Sequence Number: 20699171
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)271023(10)16308229
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: G23406
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 16308229
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 11/13/2025
• Date Device Manufactured: 10/23/2024
• 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
• Patient Sex: Unknown