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

Model Number	GIF-1TH190
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
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 the distal end cover was burnt.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added: h3, h4, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible that a high-energy endo therapy accessory (laser, high frequency, etc.) was used without ensuring a sufficient distance from distal end.However, we could not specify the cause of the suggested event.A definitive root cause could not be determined.Detection method is described in ifu: gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection_3.3 inspection of the endoscope as follows: 8 inspect the entire distal end of the endoscope including the objective lens and light guide lens for any irregularities such as scratches, chips, cracks, stains, discoloration, deformation, and gaps around the lens.There are cautions when high-energy endotherapy accessories are used in ifu: gif/cf/pcf-190 series operation manual_4.3 using endotherapy accessories.Never emit high-frequency current before confirming that the distal end of the high-frequency endotherapy accessory is in the endoscope¿s field of view.Also, confirm that the electrode section and the mucous membrane in the vicinity of the target area are at an appropriate distance from the distal end of the endoscope.If the high-frequency current is emitted while the distal end of the endotherapy accessory is not visible or too close to the distal end of the endoscope, patient injury, bleeding, and/or perforation as well as equipment damage can result.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 20363598
• Report Number: 9610595-2024-20026
• Device Sequence Number: 20528926
• Product Code: FDS
• UDI-Device Identifier: 04953170437014
• UDI-Public: 04953170437014
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112680
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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