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); Fracture (1260); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
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 that during an endoscopic retrograde cholangiopancreatography procedure under sedation, the single use retrieval nitinol basket was stuck.The team attempted primary intervention using the mechanical lithotriptor, but the ninitol basket's rod fractured.A secondary intervention was attempted to proceed with lithotripsy using emergency handle to mechanically crush, but the basket wire got bent within the bile duct preventing the coil sheath of the emergency handle from being inserted to the stone's location and thus the attempt failed.The procedure was cancelled.Reportedly, the patient was transferred to another hospital, and attempts were made to confirm the subsequent situation, but no further information was available.There were no malfunctions associated with the mechanical lithotriptor and the emergency handle used for medical intervention.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields- d8, h2, h3, h6 and h11.Corrected field- d9.Based on the results of the investigation, and since the device was discarded by the hospital staff and not returned for evaluation, the definitive root cause of the reported issue could not be determined and the cause could not be established, however, the likely cause of the device malfunction was due to factors such as stone size, hardness, shape, and the position of the basket that may have caused the wire to bend inside the bile duct during insertion of the emergency handle coil sheath.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: 23774760
• Report Number: 9614641-2025-02042
• Device Sequence Number: 9933795
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2026

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
• Device Lot Number: 58K
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/05/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERGENCY HANDLE BML-110A-1, SN/LOT UNK; MECHANICAL LITHOTRIPTOR, MAJ-441, SN/LOT UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown