MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BIOPSY VALVE

Model Number	MB-358
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the subject device exhibited adhesion of a white substance on biopsy valve lid.The issue occurred during reprocessing for a diagnostic upper endoscopy/colonoscopy.The procedure was completed with the same device.There were no reports of patient harm.
Additional Manufacturer Narrative
E1: establishment name:(documented here in it's entirety due to character limitations in respective field): (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, h2, h3, h6, h11.Corrected fields: h8.The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, analysis of the components of the collected foreign material confirmed that it was organic silicone derived from tap water and/or chemicals and was not a component derived from the endoscope.As the organic silicone detected from the foreign material was not a component derived from the endoscope, but a component of an anti-foaming agent, it is likely that the material adhered from the outside.Insufficient rinsing and/or drying may have led to the material not being removed.The event can be detected by following the instructions for use, which state: gif-1200n operation manual 3.4 inspection of accessories inspection 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 from customer.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22008846
• Report Number: 9610595-2025-08422
• Device Sequence Number: 5343057
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (Y/N): N
• PMA/510(K) Number: K051645
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: MB-358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown