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

Model Number BML-V232QR-26

Device Problem Break (1069)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The olympus representative reported on behalf of the customer, during the middle of the therapeutic gallstone removal, the single use mechanical lithotriptor v broke at the solid part of the wires where it connects to the disposable handle.As a result, it was no longer possible to make pressure with the handle to break the basket.A non-olympus emergency lithotripter was then used and while using it, the basket broke in the middle of its working length which made it impossible to keep using this lithotripter.To resolve the situation, the doctor carried out a hydrostatic dilatation (papilla dilatation) and then a fogarty balloon and a forceps for the foreign material.The basket was released from the stones and could be removed.The patient had very heavy bleeding the last 10 minutes of the procedure, which made the doctor use a covered prosthesis to ensure drainage.The bleeding may have been caused by the maneuver that was performed not related to the product breakage.The bleeding resolved by the end of the procedure.The patient was under general anesthesia and the procedure could not be completed successfully because the gallstones could not be removed in the end.After the procedure, the patient experienced fever and required an extra day of hospitalization.No further complications have been reported.

• 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
• 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: 18447305
• MDR Text Key: 332149450
• Report Number: 9614641-2024-00022
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218347
• UDI-Public: 04953170218347
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Model Number: BML-V232QR-26
• Device Lot Number: 18K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-OLYMPUS EMERGENCY LITHOTRIPTER
• Patient Outcome(s): Hospitalization; Required Intervention