MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-HQ190
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the gastrointestinal videoscope for a blurry image during inspection for use.There was no patient injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• 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: 50935166
• Report Number: 9610595-2026-80182
• Device Sequence Number: 10749755
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131780
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-HQ190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown