MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL FIBERSCOPE

Model Number	GIF-E3
Medical Device Problem Codes	Overheating of Device (1437); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the gastrointestinal fiberscope to the service center for maintenance with no complaint.During the initial evaluation of the returned device, the forceps channel was found to be clogged with melted cap material.There was no patient involvement.
Additional Manufacturer Narrative
Based on the final investigation of the device the channel was clogged with melted cap material during the initial evaluation was confirmed.A root cause could not be identified.Based on the results of the investigation, the most probable cause of channel was clogged with melted cap material is traced to component failure.Olympus will continue to monitor the field performance of this device.Should any additional relevant information become available, a supplemental report will be submitted.Date of event is unknown.Additional information will be provided once available.

• Brand Name: GASTROINTESTINAL FIBERSCOPE
• Common Device Name: GASTROINTESTINAL FIBERSCOPE
• 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: 50870398
• Report Number: 9610595-2026-78283
• Device Sequence Number: 9314145
• Product Code: FDS
• UDI-Device Identifier: 04953170152443
• UDI-Public: 04953170152443
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K954451
• 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): 09/23/2026

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: GIF-E3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• 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