MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE; Gastroscope And Accessories, Flexible/Rigid

Model Number	GIF-2TH180
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gastrointestinal videoscope had a fuzzy image.Changing the cable did not resolve the issue.The image eventually disappeared and did not return.The issue occurred during device setup.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.A root cause could not be identified.Based on the results of the investigation, the most likely cause of the fuzzy image and no image being displayed was an electrical component failure.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 GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: Gastroscope And Accessories, Flexible/Rigid
• 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 ; +1(508)207-7661
• MDR Report Key: 50913628
• Report Number: 9610595-2026-79559
• Device Sequence Number: 12094808
• Product Code: FDS
• UDI-Device Identifier: 04953170339752
• UDI-Public: 04953170339752
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: GIF-2TH180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2012
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown