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

Model Number	PCF-H180AI
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
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: for the failures "aw-cylinder (tube) has foreign objects", "aw-tube has foreign objects" and "j-tube has foreign objects", the most probable cause is cause traced to 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).In the instructions for use (ifu) it is stated: ¿nothing other than sterile water should be used for air/water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and/or infection.¿ 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
It was observed that during the device evaluation, the colonovideoscope exhibited foreign matter in the auxiliary water channel/tube (j-tube), and the air/water tube.There was no patient involvement.

• 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: 22898983
• Report Number: 9610595-2025-18974
• Device Sequence Number: 8852073
• Product Code: FDF
• UDI-Device Identifier: 04953170237300
• UDI-Public: 04953170237300
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: PCF-H180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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