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

Model Number BML-V442QR-30

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2022

Event Type  Injury  

Event Description

The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) with stone retrieval using a single use mechanical lithotriptor v with an evis exera iii duodenovideoscope (no malfunction of the scope), upon opening the basket for inspection prior to use, no issues were observed.The basket was then fed over the wire and didn¿t seem to stay close to the wire as normal.The physician tried again and inserted the basket into the biopsy channel of the scope.During this insertion the physician noticed that something wasn't working correctly and removed the basket from the scope channel.The physician inspected the device further and could see that the plastic tip of the basket that the wire feeds through was torn and therefore not holding the wire as it should.They then put the basket to one side and saved it for investigation and opened and used another basket.The physician inspected the second basket for the same issue, and it wasn't apparent.The physician used this basket as normal, no issues to the basket itself but it did get stuck around the stone.Emergency lithotripsy was used but to no avail, so the 2nd basket remains in the patient and has been sent for spyglass treatment at another facility 3 days later.The follow-up spyglass procedure was successful.The basket and stones were removed from the patient.The physician stated it was a long and technically difficult procedure, but it was managed successfully.The patient will be monitored, however, there were no immediate post-procedure concerns.Case with patient identifier (b)(6) reports the first basket used in the procedure that was retrieved.Case with patient identifier (b)(6) reports the second basket used in the procedure that broke inside the patient and required another surgical procedure to remove it.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) review for the reported lot indicated no anomaly related to the reported event.The following were reviewed: - process inspection sheet.- quality inspection sheet.- nonconforming product report.The instructions for use shipped with the device contains a warning to the user regarding this event.·never use excessive force to operate the instrument and bml handle.This could damage the instrument and/or bml handle.·make sure the screw is tightened.If not securely tightened, the pipe may detach, the basket may not to be moved, and/or the calculus may not be crushed.·make sure to have the stopper and the bml handle connected.If the instrument separates from the bml handle during operation, the pipe may break or become uncontrollable.Also, this instrument with calculus engaged may not be removed from the body.·when the lithotriptor¿s basket does not smoothly open or close, do not apply force but move the forceps elevator or the scope¿s angle back, or move the position of the basket until the basket opens or closes with ease.If the action is forced, the tube may stretch and cannot be stored inside the coil sheath.Also, the calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.·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.Conclusion: the exact cause of the problem could not be identified since the device was not retuned for evaluation; therefore, the reported phenomenon could not be confirmed.Based on the similar investigation results in the past, a likely mechanism causing the reported event might be the following.1) due to various factors such as the shape, numbers, hardness of the calculus, and the magnitude of the force necessary to close the basket, it can be inferred that a force larger than expected might have been applied to the device while the basket was grasping the calculus causing the basket to become incarcerated.2) an attempt was made to crush the calculus by using the bml-110a-1 continuously, a force more than expected applied to the device due to the various factors such as size, shape, hardness, and a force to close the basket.3) the operating wire or the basket wire broke due to excess force.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation.The device was returned for inspection, however, based on the contents of the submission and the results of the product verification, the product was that of the related complaint (patient identifier # (b)(6)).Therefore, the customer¿s complaint could not be confirmed.This supplemental report includes an update to d9 and h3 to reflect a product return.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14463440
• MDR Text Key: 293854526
• Report Number: 8010047-2022-08656
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

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: 18K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 04/04/2023; 05/03/2024
• Supplement Dates FDA Received: 10/31/2022; 04/17/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• 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: TJF-Q290V
• Patient Outcome(s): Required Intervention; Other