MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BML HANDLE V MAJ-2502

Model Number	MAJ-2502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the endoscopic retrograde cholangiopancreatography (ecpw) procedure, the stone had already been caught and was about to be crushed, the knob for crushing/closing the basket broke off with the subject device stuck.The procedure was completed by replacing it with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No new information has been provided by the customer.
Additional Manufacturer Narrative
Updated: b5, d8, d9, h2, h3, h4, h6, h11.This report is being supplemented to provide additional information based on the approved final investigation.The customer¿s allegation was confirmed.Based on the results of the investigation, the root cause of the reported issue could not be determined/identified.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BML HANDLE V MAJ-2502
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22322844
• Report Number: 9614641-2025-01052
• Device Sequence Number: 8812452
• Product Code: LQC
• UDI-Device Identifier: 04953170433658
• UDI-Public: 04953170433658
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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-2502
• Device Lot Number: 31K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown