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

Model Number	GIF-H170
Medical Device Problem Code	Thermal Decomposition of Device (1071)
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 device was returned to olympus for inspection.A definitive root cause could not be identified.Based on the results of the investigation, the presumed cause is traced to component failure, as the high-frequency treatment device was used without maintaining sufficient distance from the tip.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.This mdr was submitted during the system outage from july 22, 2026 to july 27, 2026 which may result in a delay of receipt of all of the acknowledgements.
Event or Problem Description
The customer returned the gastrointestinal videoscope, which is an olympus asset with no reported complaint.During the evaluation of the device, c-cover burn was found.There was no patient involvement.

• Brand Name: 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 ; 5082077661
• MDR Report Key: 25906241
• Report Number: 9610595-2026-58950
• Device Sequence Number: 8439188
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112680
• 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): 07/22/2026

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: Other
• Device Model Number: GIF-H170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2018
• 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