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	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation 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 distal tip for passing guidewire was torn.The issue occurred during lithotripsy performed for a therapeutic endoscopic retrograde cholangiopancreatography (ercp).The procedure was completed using the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the investigation results, inspection of the fracture surface of the low-strength guide wire distal end revealed layered resin solidification and the presence of welds.When the fracture surface of the guidewire tip with low strength was checked, the resin solidified in layers, resulting in 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.Brittle fracture was occurring starting from the weld, and the guidewire tip was prone to tearing.It was found that the guidewire tip was defective and could not be molded under optimal processing conditions.The instruction manual contains a warning to the user regarding this event.(drawing number:gk5911, revision number : 23) as a result of checking the instruction manual, the following description related to this event was found.> of the contents of the < instruction manual (fig.No.: gk5911, revision no.: 23) 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.When using a guidewire, insert this product into the forceps plug of the endoscope while holding the tip as shown in figure 4.20 and aligning the tip with the guidewire.As shown in fig.4.21, do not insert the tip at a large angle between the guide wire.Doing so may damage the guidewire tip and prevent insertion along the guidewire.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: 20129660
• Report Number: 9614641-2024-01763
• Device Sequence Number: 14259638
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS2EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 41K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: BSJ VENTY OR VISIGLIDE2, 0.025 INCH; TJF-Q290V
• Patient Sex: Unknown