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

Model Number	MAJ-210
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during an unknown diagnostic procedure that the single use biopsy valve fell apart and ripped, and part of the device ended up in the patients lung that was retrieved via suction with the scope, during a moderate sedation with fentanyl and versed, with no reports of further patient harm.There were no unplanned diagnostic imaging to locate the device as they were able to maintain visualization with the scope the entire time and then visualized the piece in the suction canister.There were no further troubleshooting performed.The remainder of the procedure was aborted.No further report of patient harm after device retrieval or reason for aborting procedure.The patient's condition was reported to be "at baseline".There were no reports of patient harm.

• 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
• MDR Report Key: 24879643
• Report Number: 2429304-2026-00036
• Device Sequence Number: 15683664
• Product Code: EOQ
• UDI-Device Identifier: 14953170152433
• UDI-Public: 14953170152433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/14/2026
• Report Date (Section F): 04/14/2026

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: H5215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Q-190 SCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/14/2026