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

Model Number	GIF-XP150N
Medical Device Problem Codes	Collapse (1099); Corroded (1131); Crack (1135); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Material Discolored (1170); Residue After Decontamination (2325); Gas/Air Leak (2946); Scratched Material (3020); Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the flex video scope exhibited the distal end had foreign objects.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: ·we could not identify the foreign material from provided information.· since the user conducted reprocessing in accordance with ifu or not was unknown from the provided information, we could not specify the cause of the foreign material remained in the device.The event can be detected/prevented by following the instructions for use which state: ifu states the detection method in gif-xp150n operation manual chapter 3 preparation and inspection.Ifu states the preventative measures in gif-xp150n reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 21724171
• Report Number: 9610595-2025-04908
• Device Sequence Number: 11744513
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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-XP150N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/28/2025
• 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