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

Model Number	GIF-XP170N
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the gastrointestinal videoscope exhibited a foreign material in the nozzle and the distal end had a burn.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.An analysis of the foreign object clogging the air and water supply nozzle was found to be protein and cellulose.As neither of these were found to be originating from the endoscope, it is likely to have been caused by the user's handling of the endoscope.Additional investigation of the burn on the plastic distal end cover concluded that this may have occurred when some kind of treatment tool or cleaning brush came into strong contact with the tip cover.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, an identification and root cause for the reported suggested malfunction(s) could not be established.The event can be detected/prevented by following the instructions for use which state: ·labeling subject event 1: a foreign material in the nozzle, subject event 3: the procedure was cancelled due to clogging of the air/water function the subject events can be detected and prevented by implementing in accordance with the below ifu.It was confirmed that instructions for gif-xp170n and gif-h170 operation manual chapter 3, ¿preparation and inspection¿ describes how to detect the events.Instructions for gif/cf-h170 series reprocessing manual chapter 5, ¿reprocessing of the endoscope (and related reprocessing accessories)¿ describes how to prevent the events.Subject event 2: the distal cover had a burn.The subject event can be detected and prevented by implementing in accordance with the below ifu.Instructions for gif-xp170n and gif-h170 operation manual chapter 3, ¿preparation and inspection¿ and chapter 4, ¿operation¿ describe how to detect and prevent the event.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20392742
• Report Number: 9610595-2024-20345
• Device Sequence Number: 6566599
• Product Code: FDS
• UDI-Device Identifier: 04953170334146
• UDI-Public: 04953170334146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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-XP170N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 02/26/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/27/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CV-170-VIDEO SYSTEM CENTER.
• Patient Sex: Unknown