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

Model Number	CF-H190I
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	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the colonovideoscope exhibited a burn on the probe cover, dirt on the objective lens, foreign objects on the probe cover, and foreign objects on the adhesive of the bending section cover.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Updated h3.Corrected g3.Correction is being made to previously submitted g3 - date received by manufacturer which was not late.The correct date was 09/24/2024.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, the reported malfunction was reproduced.Olympus confirmed that there was a foreign material.However, the type of material and the root cause could not be determined.It is unclear if reprocessing was completed per instructions for use (ifu).There was no deformation in the area where the foreign object remained.The likely cause could be that the high-energy treatment tool (laser, high frequency, etc.) was used without ensuring a sufficient distance from the tip.The event can be detected and prevented in accordance with the following instructions for use (ifu).Instruction manual cf-h190i operation manual chapter 3 preparation and inspection: 3.3 inspection of the endoscope.Instruction manual cf-h190i operation manual chapter 4 operation: 4.3 using endo therapy accessories.The detection method is described in chapter 3, preparation and inspection, of the gif/cf/pcf-190 series operation manual.Preventive measures are described in the instruction manual gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• 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: 20343628
• Report Number: 9610595-2024-19640
• Device Sequence Number: 7931308
• Product Code: FDF
• UDI-Device Identifier: 04953170436635
• UDI-Public: 04953170436635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131780
• 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
• Report Date (Section B): 11/18/2024

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: CF-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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