MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number	BML-V437QR-30
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure confirmed.On visual inspection, the brazing joint of the operating pipe was broken off.The broken part of the operating pipe stuck in the handle.After removing of the broken part that we detected that the distal part was found deformed.The coil sheath became misaligned.The basket wire was deformed a root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: due to various factors such as the shape, numbers, hardness of the calculus, a force beyond the strength resistance was applied to the device during the lithotripsy.Since the basket was deformed, the misalignment of the coil sheath had occurred.The operating pipe broke at the welded portion.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that during an elective an endoscopic retrograde cholangiopancreatography procedure under sedation with propofol, the locking rod of the single use mechanical lithotriptor broke directly at the end of the bml handle, and rest remained stuck in the handle during mechanical lithotripsy.The basket broke off from the device and remained in the patient, with the wires still attached and accessible in contact with the basket.The basket itself had enclosed a large intraductal calculus and could not initially be removed from the dhc.An emergency lithotripsy set from a third-party company was then used.The wires were inserted into this device and the stone was lithotripsied, and the defective basket was successfully retrieved from the patient by pulling it out by wires of the other device but the concretions remained inside the bile duct.The patient then underwent further treatment, including stent placement and plan a cholangioscopy with ehl.The procedure was completed with a significant delay of approximately 40 minutes the patient remained hemodynamically stable.There were no reports of patient harm or complications.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Common Device Name: SINGLE USE MECHANICAL LITHOTRIPTOR
• 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: 24525833
• Report Number: 9614641-2026-00262
• Device Sequence Number: 12892438
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: BML-V437QR-30
• Device Lot Number: 51K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SINGLE USE BML HANDLE V , MAJ-2502 , 3ZK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown