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

Model Number	BML-V242QR-30
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a therapeutic endoscopic, retrograde cholangiopancreatography (ercp) case, the single use mechanical lithotriptor, was used to grasp the stone and the coil sheath was crushed and deformed.As such, the stone could not be destroyed.Therefore, non-olympus device was used to incarcerate and break the stone.The wire was removed, and a tube stent was inserted, and procedure was completed.There was no health hazard to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and the following was observed: misalignment of the coil was observed at the distal side of the coil sheath.The fractured portion of the proximal side of the coil sheath was in the form of a tool cut.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported event was likely caused due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength may have been applied to the device during the lithotripsy.As a result, the coil sheath was likely deformed.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotripter.The pipe or the basket wire may break, and part of this instrument may remain in the body.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1.A lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.This instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.During lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.Do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.¿ this supplemental report includes additional information received from the customer.B5, b7, and h6 have been updated accordingly.Also, an update has been made to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the incident caused a 15-minute procedural delay.The wire that was removed from the patient was confirmed to be from the crusher basket.In addition, it was reported that on (b)(6) 2024, a lithotripsy was performed, and the stent was placed.The patient did not experience any complications due to the event.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18862009
• Report Number: 9614641-2024-00614
• Device Sequence Number: 8238813
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: BML-V242QR-30
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LITHOTRIPTOR HANDLE, BML-110A-1, SN-UNK; MECHANICAL LITHOTRIPTOR MAJ-441, SN-UNK; VANBECK HANDLE, MODEL#-UNK, SN-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown