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

Model Number BML-V442QR-30

Device Problem Break (1069)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the lithotriptor tore while crushing a stone in the bile duct during an endoscopic retrograde cholangiopancreatography procedure.The procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: d9, h3, h4, h6, h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation.During the evaluation, olympus confirmed the wire tip was torn.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the guide wire tip tore because lithotripsy was performed with the guide wire inserted into the guide wire tip.The event can be prevented by following the instructions for use which state: "do not crush the calculus while the guidewire remains in the distal tip.This could cause patient injury, such as perforation, bleeding or mucous membrane damage, it may also damage the endoscope and/or the guidewire and/or the instrument.1 lower the forceps elevator.2 loosen the holder, the rotatable knob, and the rack.3 when using the guide wire, pull it back.4 without releasing the calculus, turn the rotatable knob on the bml handle in the direction of the arrow.The basket crushes the calculus.1.Set the endoscope forceps table down.2.If a guidewire is used, pull it out of the lithotripter.3.While grasping the gallstone, turn on the ratchet of the bml handle v-system (maj-441).4.Rotate the knob on the bml handle clockwise to tighten and crush the gallstones with the basket." 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18899879
• MDR Text Key: 337743381
• Report Number: 9614641-2024-00650
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 41K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• 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