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

Model Number	PCF-PH190L
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
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 subject device exhibited foreign material in the air/water-cylinder and air/water tube.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction in the initial report for g3 annex: "date received by manufacturer".The previous report stated september 22, 2024.However, the correct date was october 22, 2024.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction: (d9¿ device availability; returned to manufacturer) should be: 10/20/2024.Correction: (g3 ¿ date received by manufacturer) should be: 10/22/2024.A review of the device history record found there were no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.Based on the investigation results, foreign material in a/w cylinder and foreign material in a/w channel, could not be identified.The legal manufacturer was unable to confirm if reprocessing steps were performed according to the instructions for use.We could not identify the foreign material.We could not specify root cause of the material remained in the device.Although we confirmed foreign material adhered/clogged in a/w-cylinder and a/w-channel from provided photos by sbc, could not identify the material.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿chapter 3 preparation and inspection.Chapter 5 reprocessing the endoscope¿.Olympus will continue to monitor the field performance for 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: 20521553
• Report Number: 9610595-2024-21797
• Device Sequence Number: 7880395
• Product Code: FDF
• UDI-Device Identifier: 04953170436697
• UDI-Public: 04953170436697
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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: PCF-PH190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 11/27/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2022
• 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