MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BML HANDLE V

Model Number MAJ-441

Device Problems Break (1069); Device Reprocessing Problem (1091)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported, the bml handle grip on the operating pipe was weak and came loose.The issue occurred during preperation for a therapeutic lithotripsy procedure.There were no reports of patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.G3 of the initial medwatch is being corrected to feb, 2024 and not 18 feb, 2024 as submitted.Corrections have also been made to b5 and h6.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, it is likely that the user did not properly understand the cds (cleaning disinfecting and sterilization) process.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: ·never use excessive force to operate the instrument.This could damage the instrument ·do not operate any parts with excessive force.This may lead to damage to the product.·this instrument is compatible with 2.0 ¿ 3.5% glutaraldehyde solution.However, routine biological monitoring is not feasible with glutaraldehyde and, therefore, it should not be used to sterilize reusable medical devices that are compatible with other methods of sterilization that can be biologically monitored , such as steam sterilization.·although this product is resistant to 2-3.5% glutaral preparations, we recommend autoclaving (high-pressure steam sterilization), which allows you to routinely check the sterilization effect using biological indicators.Place the sealed packages containing the instrument in the autoclave and sterilize in accordance with the conditions listed below.For details on operation of the autoclave, refer to the instruction manual for the autoclave or other manufacturer instructions.After placing the sterilized pack containing this product into the autoclave device, autoclave it under the following conditions.Other conditions should follow various cleaning and sterilization guidelines and manufacturer's instructions.Olympus will continue to monitor field performance for this device.

Event Description

The customer's reported event of a weak and loose operating pipe grip was not a reportable malfunction as initially submitted.However, upon further communication, it was found that the customer did not use autoclave sterilization, and instead used their own measures.This mdr is being submitted to note the reportable event of improper sterilization.

• Brand Name: BML HANDLE V
• Type of Device: HANDLE
• 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: 18866029
• MDR Text Key: 337219867
• Report Number: 9614641-2024-00621
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218446
• UDI-Public: 04953170218446
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-441
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BML-V437QR-30 SINGLE USE MECHANICAL LITHOTRIPTOR V; TJF-Q290V