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

Model Number	CF-Q165I
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
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 colonovideoscope exhibited foreign material inside the air/water cylinder and air/water tube.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, and the lms final investigation.New information added to the following field(s): h3 and h6.The device was returned for evaluation where the reported event was identified.Based on the results of the investigation, the user possibly could not perform reprocessing properly due to leakage from guide pin on the electrical connector caused by damage or leakage from the bending section cover rubber.The foreign material could not be specified and a definitive root cause cannot be identified.Physical damage was not noted to have been found at the foreign material residue points and from the information obtained, it is unclear whether the reprocessing was carried out in accordance with the ifu, so the cause of the foreign material remaining could not be determined.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject event can be detected and prevented by implementation in accordance with the below ifu.Detection method is described in evis exera ii gif/cf type 165 series operation manual chapter 3 preparation and inspection.Preventive measures are described in evis exera ii gif/cf type 165 series reprocessing manual cleaning, disinfection and sterilization procedures.Olympus will continue to monitor the field performance of this device.

• 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: 20391061
• Report Number: 9610595-2024-20316
• Device Sequence Number: 12399366
• Product Code: FDF
• UDI-Device Identifier: 04953170339684
• UDI-Public: 04953170339684
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K001241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: CF-Q165I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2014
• 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