MAUDE Adverse Event Report: GYRUS ACMI, INC. URO GUIDE 6 FR X 26 CM; STENT, URETERAL

Model Number	5496026
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implanted stent migrated causing patient discomfort.The patient had another procedure wherein the stent was removed and a new (unknown manufacturer) stent was placed.Additional information has been requested; however no further information has been available at this time.The device was inspected prior to use.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to previously submitted initial report g3 which should have been july 26th, 2024 and not september 6th, 2024.The report was submitted with september 6th, 2024 as the g3 date which signifies when additional information was received about another procedure needing to be performed to replace the stent.This information was to accommodate the update in b1 to adverse event.However, the customer reported the product problem on july 26th, 2024 when they alleged that the stent migrated.Therefore, the g3 date of the initial report should have been july 26th, 2024.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.The subject device was not returned to olympus for evaluation.However, an unused device from the same model/lot was returned to olympus by the facility.The device was received in its original packaging, sealed, and with no damage or abnormalities observed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.The subject device was not returned to olympus for evaluation.Based on the results of the investigation, the root cause of the reported event could not be determined.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: URO GUIDE 6 FR X 26 CM
• Common Device Name: STENT, URETERAL
• 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: 20279968
• Report Number: 3011050570-2024-00385
• Device Sequence Number: 7987438
• Product Code: FAD
• UDI-Device Identifier: 00821925004641
• UDI-Public: 00821925004641
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K830884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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: 5496026
• Device Lot Number: MQQX390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 10/28/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2023
• 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