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	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a fragment of the single-use biopsy valve detached and fell into the bronchus during a diagnostic endobronchial ultrasound with a guide sheath (ebus-gs) procedure for specimen collection.The event occurred while the patient was under sedation and the device was in use.The detached fragment was retrieved using biopsy forceps, and all components were reported to have been retrieved.The procedure was completed using an olympus backup device.No serious injury or adverse patient effects were reported.
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6) hospital.The device was returned to olympus for inspection, and the reported failure was confirmed.A definitive root cause could not be determined.Based on the results of the investigation, it is possible that the biopsy valve broke due to stress caused with inserting or removing the syringe at an angle.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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 ; +1(508)207-7661
• MDR Report Key: 50919682
• Report Number: 3003637092-2026-00189
• Device Sequence Number: 17593405
• 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
• Report Date (Section B): 09/28/2026

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
• Device Lot Number: H6304
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2026
• 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: BF-260.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown