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

Model Number	BML-V437QR-30
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use mechanical lithotriptor v lithocrush had the wires come completely out of the sheath when we tried to pull the basket out of the duct.It occurred during an unspecified procedure.There was a less than 30 minutes delay, and the same device was used to complete the procedure.There were 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.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being submitted to provide the results of the final investigation and provide a correction to a previously submitted report.Corrected fields: h6.The device was returned to olympus for inspection, and the reported failure was confirmed.The device underwent a visual inspection; however functional tests weren't possible due to missing components not returned along with the sheath.The device was received missing the basket wire pipe which is intact with the basket wire, basket, and distal tip.The sheath was inspected and there are no indications of heavy kinks or excessive bends.The injection port has no signs of cracks or breaks on the connector.A dimensional inspection was not performed as the missing components were not returned along with the sheath.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: component failure.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 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: 21738378
• Report Number: 9614641-2025-00407
• Device Sequence Number: 19828875
• Product Code: LQC
• UDI-Device Identifier: 04953170462610
• UDI-Public: 04953170462610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS2-EXMPT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: BML-V437QR-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown