MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II COLONOVIDEOSCOPE

Model Number	PCF-Q180AL
Medical Device Problem Codes	Device Reprocessing Problem (1091); Corroded (1131); Crack (1135); Degraded (1153); Electrical /Electronic Property Problem (1198); Gas/Air Leak (2946); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the flex video scope exhibited air/water-cylinder (tube) had foreign objects and the sheet holder unit had corrosion due to water leakage.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the most probable cause of the failure "aw-cylinder (tube) has foreign objects" is known inherent risk of device, which indicates that the reported adverse event is known and documented in the labeling and all reasonable mitigation steps have been taken (including both short or long term known complications or adverse reactions).The most probable cause of the failure "sheet holder unit has corrosion due to water leakage." is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.The event can be detected by following the instructions for use which state: the white foreign material detected by income inspection has been handled by omsc capa-201632.According to previous investigations, the use of products that contain silicone can cause deposits of white foreign material.Silicone is for example included in simethicone, a defoaming agent, lubricants and so on.If the customer used them, there was risk that foreign material was remained in the channel even if the reprocessing was conducted in accordance with ifu.Simethicone and petroleum/oil/silicone-based lubricants are non-water soluble and thus not recommended for use by olympus.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• 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: 22576308
• Report Number: 9610595-2025-15029
• Device Sequence Number: 9576907
• Product Code: FDF
• UDI-Device Identifier: 04953170202544
• UDI-Public: 04953170202544
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: Other
• Device Model Number: PCF-Q180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2007
• 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