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

Model Number	BML-V242QR-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported the following event happened two (2) times in one month involving the subject device.The following is for patient 1 of 2 which has been reported in (b)(4).The customer reported to olympus, during a therapeutic ercp for a common bile duct (cbd) stone retrieval, last thursday, the subject device was used to crack a large stone when the basket jammed within the common bile duct.The pigment gallstone was 12-15mm.The surgeon used the emergency mechanical lithotriptor but was unable to remove the basket.The surgeon felt tension between the emergency mechanical lithotriptor and the cut subject device.The breaking point of the subject device was at the proximal end only and not the distal end with basket.Spyglass was used to complete the procedure to break the stone and remove from cbd.It is unclear how the broken device was removed from the patient.The following is for patient 2 of 2 and is being reported in (b)(4).The customer reported the event for patient 1 also happened to patient 2.No additional details provided.Two events reported: (b)(4): event 1, (b)(4): event 2.This report is 1 of 2 for (b)(4): event 1.
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 returned to olympus for inspection, and the findings are as follows: only the operating wire with basket was returned to aomori olympus.The operating wire was broken at approximately 860 mm from the root of basket.A ductile fracture was found at the broken portion.The outer diameter of the broken wire was measured, and the result indicated no abnormalities.The basket was not remarkably deformed.Based on the provided picture, the coil misalignment occurred at the proximal side of the coil sheath.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, although the toot cause could not be identified, the following mechanism likely caused the reported issue: 1.Due to various factors such as the shape, numbers, hardness of the calculus, a force beyond the strength resistance was applied to the device during the lithotripsy.2.Due to the description above ¿1¿ description, the basket got stuck.The coil sheath misalignment occurred.3.The lithotripsy was kept on going by combing emergency lithotripter and the subject device.However, a force beyond the strength resistance was applied to the operating wire due to various factors such as the shape, numbers, hardness of the calculus.4.Due to the description above ¿3¿ description, the operating wire was broken.Therefore, the basket could not be removed by the emergency lithotripter.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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 type of damage shown in ¿emergency treatment¿ may occur.Use this instrument with the consideration that the instrument may be damaged, 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.¿ olympus will continue to monitor field performance for this device.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15501590
• Report Number: 9614641-2022-00375
• Device Sequence Number: 12122179
• Product Code: LQC
• UDI-Device Identifier: 04953170218392
• UDI-Public: 04953170218392
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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: TJF-Q290V, UNKNOWN SERIAL
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown