MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE BIOPSY VALVE (STERILE)

Model Number	MAJ-210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported during a diagnostic endobronchial ultrasound (ebus) procedure, while inserting the guide sheath a piece of the single use biopsy valve fell off into the bronchus.The fallen piece was retrieved.The tool and method used for retrieval were unknown.The procedure was completed with a replacement device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation updated fields: d9, h2, h3, h6, h7, h9, h11.The device was returned to olympus for inspection and the reported failure was confirmed.The device evaluation found that part of the biopsy valve was broken, and a broken piece had fallen off.It was also confirmed that the broken piece had been retrieved.The shape of the detached rubber fragment matched that of the damaged portion of the biopsy valve, leading to the conclusion that the detached rubber fragment was part of the biopsy valve.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: this event was caused by a component failure of the biopsy valve.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received form customer.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Common Device Name: SINGLE USE BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24706349
• Report Number: 3003637092-2026-00065
• Device Sequence Number: 10151120
• Product Code: EOQ
• UDI-Device Identifier: 14953170152433
• UDI-Public: 14953170152433
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003637092-12/29/2025-00
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: K-401 SINGLE USE GUIDE SHEATH KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown