MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. Single Use Mechanical Lithotriptor V; Lithotriptor, Biliary Mechanical

Model Number	BML-V232QR-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic endoscopic retrograde cholangiopancreatography while removing a stone, the basket cable broke in the proximal area.The doctor used the emergency lithotriptor handle an attempt to remove the single use mechanical lithotriptor and the cable broke again, this time in the distal area, next to the basket, leaving the stone and the basket inside the patient.As such the procedure was delayed for equal to or greater then 30 minutes under sedation, completed with a competitors device.No reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: Single Use Mechanical Lithotriptor V
• Common Device Name: Lithotriptor, Biliary Mechanical
• 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 ; +1(508)207-7661
• MDR Report Key: 50090758
• Report Number: 9614641-2026-00795
• Device Sequence Number: 10478912
• Product Code: LQC
• UDI-Device Identifier: 04953170218361
• UDI-Public: 04953170218361
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (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): 08/19/2026

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: BML-V232QR-30
• Device Lot Number: 58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/19/2026
• 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: BML-610A (Single Use Mechanical Lithotriptor).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown