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

Model Number	BML-V442QR-30
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
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 the subject device distal tip was torn.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of the legal manufacturer's final investigation.Corrected fields: d7a.The device was not returned to olympus for inspection, therefore the customer's reported issue could not be confirmed.Based on the results of the investigation, a definitive root cause could not be determined as the device was not returned.However, based on the examination of an in-house inventory guide wire, the distal end likely did not meet strength specification due to suboptimal molding conditions.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the updated investigation.Additional information added to the following fields: d8, d9, h2, h3, h6.The device was returned to olympus for inspection and the customer's reported issue was confirmed.The guidewire tip was torn and the fracture shape suggests a brittle fracture.It was further noted that brittle fractures originate at the welds, making the guide wire distal end more susceptible to tearing.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely the event occurred because the guide wire distal end did not meet strength specifications due to suboptimal molding conditions during manufacturing.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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: 21255647
• Report Number: 9614641-2025-00093
• Device Sequence Number: 13009084
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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 Expiration Date: 10/31/2025
• Device Model Number: BML-V442QR-30
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 03/06/2025; 05/01/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/31/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown