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

Model Number	MAJ-210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 that the single use biopsy valve had the internal seal ring damaged while anesthetic was being administered via syringe.The issue occurred during a diagnostic bronchoscopy.There was no delay reported and it was completed with a similar device.There were no reports of patients¿ harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updates fields: b5, d9, g3, h2, h3, h6 and h11.The device was returned to olympus for inspection.Based on the investigation results and past findings, reasonably known information suggests potential causes is likely the damage occurred when forceful insertion or removal of the syringe, or insertion/removal at an angle, applied stress to the slit section inside the biopsy valve.The most probable cause of this complaint is a component failure.However, a definitive root cause pf reported issue could not be identified.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplement is being submitted to make corrections to - d4, d5, h3, h7 and h9.Update - h11.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from 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: 24580331
• Report Number: 3003637092-2026-00051
• Device Sequence Number: 9435529
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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-210
• Device Lot Number: 103710401010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 03/23/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/12/2026; 04/17/2026
• 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: 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
• Patient Sex: Unknown