MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	GF-UCT180
Medical Device Problem Codes	Device Reprocessing Problem (1091); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided once available.\ \ the final investigation has been completed.The failures identified during the inspection have been confirmed.\ \ a root cause for the foreign object events could not be identified.Based on the results of the investigation, the most likely causes were not established.\ \ a root cause for the chipped adhesive event could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: expected or random component failure without any design or manufacturing issue.\ \ olympus will continue to monitor the field performance of this device.\ \ should any additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue.During the device analysis, the service repair technician indicated that the following malfunctions were found: an objective lens cleaning failure, distal end residue, a chip in the adhesive area between the distal end and the light guide cover, and the forceps elevator pipe was clogged with foreign substances.There was no patient involvement.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50761643
• Report Number: 3002808148-2026-32195
• Device Sequence Number: 15786197
• Product Code: ODG
• UDI-Device Identifier: 04953170287879
• UDI-Public: 04953170287879
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/05/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/05/2026
• Initial Report FDA Received Date: 09/14/2026
• 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