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	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the evaluation confirmed the event in section b5 of this report.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The device was returned, and the evaluation found the distal tip for passing the guidewire was torn.A similar device was used to complete the procedure and there was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
Corrected fields: b5 (information was inadvertently missed), d4 (udi was inadvertently missed) this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be conclusively determined.However, it is likely the guide wire tip tore due to one of the following: 1.An attempt was made to insert the device into the endoscope while using the guide wire.2.When the angle between the distal end and the guide wire was large, the device was inserted into the endoscope.3.A force exceeding the resisting force was applied to the guide wire tip.This caused the guide wire tip to tear.The instructions for use (ifu) contains the following information regarding this event: "·when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip as shown in figure 4.20.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 4.21.This may damage the distal tip." olympus will continue to monitor field performance for this device.
Event or Problem Description
The reported issue occurred during a therapeutic procedure.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18784305
• Report Number: 9614641-2024-00478
• Device Sequence Number: 7861037
• Product Code: LQC
• UDI-Device Identifier: 04953170218415
• UDI-Public: 04953170218415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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-V442QR-30
• Device Lot Number: 3ZK04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• 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
• Patient Sex: Unknown