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

Model Number	CF-Q180AI
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, the foreign material was unable to be identified and there was no physical damage at the place where the foreign material remained.Additionally, as no information was obtained, deviations from instruction for use (ifu) are unknown.Therefore, the root cause of the reported event is unable to be conclusively determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The events can be detected and prevented in accordance with the following ifu.Ifu states that detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the colonovideoscope exhibited a whitish foreign material was found inside the air/water-tube and inside the air/water-cylinder.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was evaluated and as per device evaluation, the reported issue was likely a result of insufficient reprocessing.In addition to reportable finding mentioned in reportable event description, the device evaluation found following findings: air/water-cylinder and suction-cylinder had no color; forceps channel port was shaved; channel cleaning brush could not be inserted smoothly due to deformation of channel mount unit; bending angle in up direction did not meet the standard value due to wear of angle wire; there was a crack on light guide lens and universal cord had a wrinkle.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: EVIS EXERA II 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: 18610169
• Report Number: 9610595-2024-02018
• Device Sequence Number: 2465951
• Product Code: FDF
• UDI-Device Identifier: 04953170307690
• UDI-Public: 04953170307690
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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: Health Professional
• Device Model Number: CF-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2007
• 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