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

Model Number	GIF-Q150
Medical Device Problem Codes	Degraded (1153); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: foreign objects in the nozzle, sticky connecting tube, sticky image guide protector and damaged on charged coupled device unit resulting in specified power to not be obtained.A root cause could not be identified.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.A definitive root cause cannot be determined.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: known inherent risk of device.Date of event is unknown.Additional information will be provided if available.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer returned the gastrointestinal videoscope to the service center for a separate issue.During the device analysis, the investigation indicates that foreign objects in the nozzle, sticky connecting tube, sticky image guide protector and damaged on charged coupled device unit resulting in specified power to not be obtained 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: 25623026
• Report Number: 9610595-2026-51723
• Device Sequence Number: 10116084
• Product Code: FDS
• UDI-Device Identifier: 04953170307485
• UDI-Public: 04953170307485
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051645
• 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): 06/25/2026

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-Q150
• Device Lot Number: 2222872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/25/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown