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

Model Number BML-V242QR-30

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 321672341
• Report Number: 2429304-2023-00266
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2023,09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention