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
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.

• 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
• MDR Report Key: 22039474
• Report Number: 2429304-2025-00147
• Device Sequence Number: 8899110
• Product Code: LQC
• UDI-Device Identifier: 04953170462610
• UDI-Public: 04953170462610
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025
• Report Date (Section F): 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: LOT48K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 11/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BML-110A-1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/03/2025