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

Model Number	GIF-HQ190
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the videoscope had a fuzzy image.There were no reports of patient harm as a result of this event.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, since the customer¿s allegation was not reproduced, a root cause could not be identified.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 III 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: 50923547
• Report Number: 9610595-2026-79865
• Device Sequence Number: 5778319
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 09/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• 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: 04/08/2022
• 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