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 Codes	Entrapment of Device (1212); Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested from the customer including further patient impact and the cause of the delay in reporting the event, but no response was received at the time of report.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 that during a therapeutic endoscopic retrograde cholangiopancreatography involving complex anatomy, the single use retrieval nitinol basket v did not break at the predetermined breaking point; as a result, the stone could not be fragmented, and the basket remained inside the patient.The procedure was prolonged by greater than or equal to 30 minutes.On (b)(6) 2025, the patient underwent another procedure, during which both the basket that had remained inside the patient and the stone were successfully removed.There were no reports of further patient harm.
Event or Problem Description
It was reported that the endoscopic retrograde cholangiopancreatography procedure was delayed by 57 minutes.Propofol intravenous sedation was administered; however, no complications arose from the prolonged sedation.A two-stage procedure was necessary.The detached basket did not need to be surgically removed but could be mechanically mobilized in a second procedure and removed completely without complications.The hospital stay was prolonged, and antibiotics were required for a total of 7 days.The patient's condition after the second procedure was unremarkable.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the customer and the results of the final investigation.Updated fields: b2, b5, h2, h6, h11 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.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for 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: 24786826
• Report Number: 9614641-2026-00352
• Device Sequence Number: 12295516
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: FG-V451P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/05/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown