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

Model Number	GIF-EZ1500
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
The final investigation has been completed.The failure reported by the customer and identified during the inspection has been confirmed.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 malfunctions is traced to component failure.Olympus will continue to monitor the field performance of this field performance of this device and evaluate any additional information received through post-market surveillance activities.

• Brand Name: 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: 50410599
• Report Number: 9610595-2026-68666
• Device Sequence Number: 18429824
• Product Code: FDS
• UDI-Device Identifier: 04953170423628
• UDI-Public: 04953170423628
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K250432
• 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,Followup
• Report Date (Section B): 09/22/2026

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-EZ1500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2026
• 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