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

Model Number	BML-V442QR-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the single use mechanical lithotriptor v tip was torn.The event occurred during endoscopic retrograde cholangiopancreatography.A similar device was used to complete the operation and there were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.New information added: d8, h4: the subject device was manufactured in apr.2024, h6.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 subject device was not returned to aomori olympus.Therefore, the condition of the device could not be confirmed.In-house inventory guide wire distal end found that its strength did not meet specifications, and the breakage pattern showed tearing, similar to the product in the reported event.Inspection of the fracture surface of the low-strength guide wire distal end revealed layered resin solidification and the presence of welds.Brittle fractures originated at the welds, making the guide wire distal end more susceptible to tearing.This suggests a molding defect in the guide wire distal end, indicating that it was not molded under optimal processing conditions.The cause of this event was that the guide wire distal end did not meet strength specifications due to suboptimal molding conditions during manufacturing.A definitive root cause of the reported issue could not be determined.The instruction manual contains a warning to the user 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.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 5.This may damage the distal tip.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20392490
• Report Number: 9614641-2024-01953
• Device Sequence Number: 20474461
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 44K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/06/2024
• 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
• Patient Sex: Unknown