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

Model Number	BML-V437QR-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00147.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 during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) with stone extraction procedure, when the physician tried to crush the stone with the basket, the cable broke inside the patient.The cable link barely came out of the patient's mouth and it was not long enough for it to fit through the sheath to use the emergency handle.The stone and broken basket were eventually extracted.This resulted to the delay of the procedure for about 3 hours on (b)(6) 2025 and the patient was brought back in on (b)(6) 2025 and procedure lasted almost 2 hours.The procedure was then completed with a laser, extraction balloon, and a rat tooth forceps, and needle knife.The physician stated there were no complications but the stone was unable to be crushed.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00147.This report is being supplemented to provide additional information based on the final investigation.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The most probable cause of the event is that the load beyond the resistance strength might have applied to the product during the stent removal.As a result, the basket wire was broken.However, the exact cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 22039486
• Report Number: 9614641-2025-00763
• Device Sequence Number: 18367585
• Product Code: LQC
• UDI-Device Identifier: 04953170462610
• UDI-Public: 04953170462610
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: 48K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: BML-110A-1.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown