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

Model Number	PCF-PH190I
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
Event or Problem Description
The customer reported to olympus, the evis exera iii colonovideoscope experienced an image issue.The device was returned for evaluation.During the device evaluation, white foreign material was found in the air water tube and cylinder.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found the suction cylinder had no color, the plug unit had corrosion, the scope cover unit had corrosion due to water leakage, the circuit board unit in the suction connector had corrosion due to water leakage, the play of the up down knob was out of the standard value due to wear of the angle wire, the light guide lens had a crack, and the adhesive on the bending section cover had a crack.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.When the foreign material was identified, olympus requested additional information from the customer on their reprocessing practices.No response was received from customer after multiple attempts to contact them.During device investigation, the reported image issue was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device instructions for use document was reviewed.Review showed relevant instruction related to detection of the issue in chapter 3: preparation and inspection.Also, the reprocessing manual provides relevant prevention steps in chapter 5: reprocessing the endoscope.Based on the results of the investigation, the foreign material could not be identified nor the specific root cause of why the foreign material remained in the device.There was no physical damage where the foreign material was found.Based on the customer feedback received, it is unknown whether there were deviations from the device instructions during customer reprocessing.A definitive root cause of the foreign material on the scope could not be identified.Olympus will continue to monitor 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: 18360499
• Report Number: 9610595-2023-19917
• Device Sequence Number: 8015219
• Product Code: FDF
• UDI-Device Identifier: 04953170436710
• UDI-Public: 04953170436710
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: Health Professional
• Device Model Number: PCF-PH190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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