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

Model Number	BML-V242QR-30
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus during a diagnostic endoscopic retrograde cholangiopancreatography (ercp), the single use mechanical lithotriptor had two failures and a modification to the device was required to complete the case.The flower basket handle was removed from the device in order to use the emergency lithocrush handle and the sheath had to be cut emergently.The procedure duration was around 4 hours which was very prolonged due to the product failure and anesthesia was also extended.The reported problem did not affect the outcome of the procedure.The procedure was completed with the emergency lithocrush.
Event or Problem Description
This supplemental report is being created to include additional information received from the customer.When the original device was connected, no pressure was being applied to the stone and the handle retracted all the way out and then continued spinning.The handle was reattached with the same result leading the device to fail, therefore the rescue device was applied.Tension and pressure were applied in attempt to crush the stone, however the wire broke inside the rescue handle.The sheath surrounding the wire was then cut to modify the device and give more wire to wrap in the rescue handle.The emergency handle was able to start turning the wires and the stone was then crushed.

• 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: 17597384
• Report Number: 2429304-2023-00266
• Device Sequence Number: 7402652
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023
• Report Date (Section F): 07/25/2023

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-V242QR-30
• Device Lot Number: 16K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown