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

Model Number	MAJ-441
Medical Device Problem Codes	Problem with Sterilization (1596); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegations were confirmed.The device evaluation found the stopper and the wire joint release button were stuck.During reprocessing, ultrasonic cleaning was used and did not use autoclave sterilization.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, during preparation for use, the lock on the front of the bml handle v did not engage.The device was replaced with a similar device and the procedure was completed.The customer also reported that during reprocessing, ultrasonic cleaning was used and did not use autoclave sterilization.There were no reports of patient harm.
Additional Manufacturer Narrative
H4: based on the 3 digit lot#, the device was manufactured in june 2021 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause of the facility not performing autoclave sterilization on the lithotriptor handle could not be determined, however, the issue was likely due to the user's incorrect understanding of the cleaning, disinfection, sterilization (cds) process.The event may be detected/prevented by following the instructions for use which state: rk0402 edition no.03 - 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) so that the sterilization effect can be confirmed on a daily basis 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.

• Brand Name: BML HANDLE V
• Common Device Name: 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: 18000912
• Report Number: 9614641-2023-01584
• Device Sequence Number: 7637873
• Product Code: LQC
• UDI-Device Identifier: 04953170218446
• UDI-Public: 04953170218446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-441
• Device Lot Number: 16K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown