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

Model Number	BML-V232QR-30
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of therapeutic endoscopic retrograde cholangio pancreatography ercp procedure in a 80 year old, caucasian, female patient, the lithotriptor handle broke due of the size (30mm stone) and hardness of the stone in common bile duct.The procedure was unable to be completed and the patient was transferred to the hospital in the operating room wherein a emergency surgical procedure was conducted and the stone was able to be removed.The procedure turned out well according to the physician.Reportedly, the stone was a biliary stone.The part of the lithotriptor handle that broke was cranked on the handle.The stone was too strong, when the user put the ratchet on and went to crank, no tension was created.This indicates the basket was still tightening around the stone to crush it.The stone was able to be removed surgically.Follow-up information received that the patient made a full recovery with no adverse effects or complications reported.No pre-existing conditions reported.The patient was discharged.The report is related to the following linked patient identifier (b)(6).

• 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: 19331550
• Report Number: 2429304-2024-00259
• Device Sequence Number: 7009757
• Product Code: LQC
• UDI-Device Identifier: 04953170218361
• UDI-Public: 04953170218361
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024
• Report Date (Section F): 11/15/2023

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-V232QR-30
• Device Lot Number: N2302830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BML HANDLE V, MAJ441, SN-(B)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female