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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during endoscopic retrograde cholangiopancreatography, stone extraction, the basket got broken from the distal end, then the wire also got broken after trying with "sohendra." furthermore, the customer explained that the lithotripsy basket impacted into the common bile duct as they tried to crush the stone.Suddenly, the basket broke from the handle.Then, they tried to use the emergency lithotripter to break the basket to retrieve it, unfortunately, the basket cable itself got broken.The procedure was not completed, the patient was sent for surgery.The procedure was delayed for more than one hour.The extension of the procedure was considered to have caused a serious health deterioration.The device was inspected before use and no defect was found.Additional information has been requested, but no further information has been received at this time.

Event Description

Olympus further received information that the patient went for surgery to remove the basket.The broken devices were retrieved during the surgery.The patient condition is currently fine.

Manufacturer Narrative

This report is being supplemented to provide additional information received.Updated fields: b5, h6.

Event Description

The procedure was a therapeutic procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction with information inadvertently left out (b5) and to provide a correction to fields.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation confirmed the following: the operating wire has been removed from the tube sheath.The operating pipe was broken at the brazing joint of the operating wire.The operating wire was broken at its distal side.The broken portion showed the characteristics of ductile fracture.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 and investigation results in the past, a likely mechanism causing the reported event could be the following: 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, coil misalignment of the sheath occurred, and the operating pipe broken.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 broken, and the basket fell into the body.Therefore, the basket could not be removed from the body by the emergency lithotripter.However, the root cause of the reported event could not be identified.The event can be prevented by following the instructions for use 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 lithotripter bml-110a-1." "a lithotripter 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 lithotripter 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." "lower the endoscope¿s forceps elevator when performing lithotripsy.If lithotripsy is performed when the elevator is not lowered, the scope or the instrument may break and/or the calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body." "do not use this lithotripter bml-110a-1 for a calculus that is assumed impossible to be crushed by this lithotripter.The basket wire etc.May break and part of this lithotripter 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 lithotripter bml-110a-1." "the operation of the mechanical lithotripter bml-110a-1 is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard and the basket wire or mechanical lithotripter is damaged, lithotripsy cannot be continued.Use the bml-110a-1 with the understanding that its basket wire could become damaged and that open surgery may have to take place." "if the calculus is too hard, it is possible that the damages shown below and other damages may have occurred.In addition, before using the bml-110a-1,thoroughly review its instruction manual and use it as instructed." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18131011
• MDR Text Key: 328043659
• Report Number: 9614641-2023-01706
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

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-V442QR-30
• Device Lot Number: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/20/2023; 02/06/2024
• Supplement Dates FDA Received: 11/28/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Outcome(s): Required Intervention