MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RETRIEVAL NITINOL BASKET V; SINGLE USE RETRIEVAL BASKET

Model Number	FG-V451P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the subject device they attempted to pull the basket back into the sheath, but it would not open.They then removed the scope and extracted the device, yet it still failed to reopen.The procedure was completed using a backup device.This is occurred during a there were no reports of patient harm.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: h2, h4, h6, h11.The device was not returned for evaluation and the customer's allegation could not be confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Common Device Name: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21606088
• Report Number: 9614641-2025-00312
• Device Sequence Number: 8756926
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: FG-V451P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown