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

Model Number	PCF-H190I
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During visual examination the following additional issues were found: the scope cover was cracked; the connector cover was cracked; the light guide lens was cracked; and the adhesive on the bending section cover was worn.During functional testing, the device did not meet electrical resistance specifications due to damage to the bending section cover's adhesive.Further, the image was partially dark due to a scratch on the objective lens.Finally, the bending angle in the up direction did not meet the specifications due to worn angle wire.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus that the evis exera iii colonovideoscope had a halo on the image.This issue was found during customer reprocessing.The device was returned to olympus for evaluation.During evaluation, foreign material was found in the air/water cylinder and in the air/water tube.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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, it is not possible to establish the root cause.The events can be detected and prevented in accordance with the following instructions for use (ifu).Ifu states that detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.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: 18095209
• Report Number: 9610595-2023-16728
• Device Sequence Number: 12432560
• Product Code: FDF
• UDI-Device Identifier: 04953170436673
• UDI-Public: 04953170436673
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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