MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 11/13FR X 46 CM 5/BX

Model Number	61146BX
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the uropass access sheath was damaged when it was taken out of the box.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additional information: d8, d9, h3, h4, h6, h11.The device was returned to olympus for inspection and it was confirmed that the tip was bent.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause was not determined.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Common Device Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20457753
• Report Number: 3011050570-2024-00434
• Device Sequence Number: 7765825
• Product Code: KNY
• UDI-Device Identifier: 00821925035379
• UDI-Public: 00821925035379
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051593
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 61146BX
• Device Lot Number: 09G2300141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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
• Patient Sex: Unknown