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

Model Number BML-V442QR-30

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2024

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus.Therefore, the customer reported issue could not be confirmed.Based on the results of the investigation, a likely mechanism causing the reported event might be the following.1) an attempt was made to insert the device into the endoscope while using the guide wire.2) when the angle between the distal end and the guide wire was large as shown in the following figure, the device was inserted into the endoscope.(see fig.1) 3) a force exceeding the resisting force was applied to the guide wire tip.This caused the guide wire tip to tear.However, the root cause of the reported event could not be conclusively identified.The subject device was manufactured on september 2023 based on the provided 3 digit lot information.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): (drawing number:gk5909, revision number : 21) ·when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip as shown in figure 4.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 5.This may damage the distal tip.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the single use mechanical lithotriptor, when threading the basket onto the guide wire, the nose was cut through or it was already cut when the basket was unpacked.The issue occurred during an unspecified therapeutic procedure.There were no reports of patient harm.

• 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: 19118841
• MDR Text Key: 341004088
• Report Number: 9614641-2024-00922
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BML-V442QR-30
• Device Lot Number: 39K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• 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