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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lid part of the single use biopsy valve broke and fell off during an unspecified procedure.There was no report of patient/user harm.
Additional Manufacturer Narrative
E1- initial reporter establishment name: (b)(6) hospital.The device was not returned to olympus for inspection; therefore, the reported malfunction could not be confirmed.Based on the completed investigation, the root cause of the reported malfunction could not be definitively determined.Should any additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of 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 ; 5082077661
• MDR Report Key: 25048746
• Report Number: 3003637092-2026-00103
• Device Sequence Number: 10457983
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown