MAUDE Adverse Event Report: GYRUS ACMI, LLC OLYMPUS; DISLODGER, STONE, FLEXIBLE

Model Number	NT4W22115
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus ultra-catch nt- no tip nitinol basket doesn't work.

• Brand Name: OLYMPUS
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, LLC; 800 west park drive; westborough MA 01581
• MDR Report Key: 23050530
• Report Number: 23050530
• Device Sequence Number: 9512422
• Product Code: FGO
• UDI-Device Identifier: 00821925027701
• UDI-Public: (01)00821925027701
• 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): 08/29/2025
• Report Date (Section F): 08/29/2025

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
• Device Model Number: NT4W22115
• Device Lot Number: KR498877
• 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: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Date Report Sent to FDA: 08/29/2025