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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e1 (telephone number added was missing from the initial medwatch) g2 (user facility added was missing from the initial medwatch).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) year since the subject device was manufactured.Based on the results of the investigation, although the adherence/clogging of the material was confirmed, we could not identify the material.Therefore, a definitive root cause could not be determined.It is likely the foreign material may not have been removed because reprocessing could not be conducted properly due to leakage at scope-cover.The customer did not provide a cleaning disinfection and sterilization checklist, so it is unknown if there were any deviations.Whether there was deviation from ifu in reprocessing steps for the area foreign material remained or not was unknown.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿the instruction manual gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection describes how to detect for the suggested events.The instruction manual gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope describes how to prevent for the suggested events.¿ 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 the air/water (a/w) tube and cylinder had foreign material.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation found no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 18718519
• Report Number: 9610595-2024-03334
• Device Sequence Number: 7245861
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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-PH190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2023
• 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