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

Model Number	CF-Q180AI
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
It was observed that during the device evaluation, the flex video scope exhibited the jet-tube, air/water tube, and air/water cylinder with foreign material.There were no reports of patient involvement.
Additional Manufacturer Narrative
The legal manufacturer's investigation is ongoing, this report will be supplemented when new and relevant information becomes available.The device was visually inspected, and functional testing was performed.Based on functional testing performed, the device failed the standard specification.A review of the device history record found no deviations that could have caused or contributed to the reported issue.
Additional Manufacturer Narrative
This supplemental report is being submitted, to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d4, h6.Corrected field: d5.(added "olympus" in operator device).A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over eighteen (18) years, since the subject device was manufactured.Based on the results of the investigation, the foreign material was identified, as simethicone.It is possible, that the presence of this foreign material was, due to insufficient cleaning.It¿s also likely, that the foreign material may not have been removed, because the reprocessing might not have been conducted properly.No physical damage to the device was confirmed, at the location where the foreign material remained.However, a definitive root cause could not be determined.The legal manufacture reviewed: the customer provided the cleaning disinfection and sterilization (cds) processes.Where no obvious deviations from instructions for use (ifu) were identified.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use:  the instruction manual evis exera ii gif/cf/pcf, type 180 series, operation manual chapter 3: preparation and inspection: describes how to detect for the suggested events.  the instruction manual evis exera ii gif/cf/pcf, type 180 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.

• 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: 19197842
• Report Number: 9610595-2024-08800
• Device Sequence Number: 7616275
• Product Code: FDF
• UDI-Device Identifier: 04953170307690
• UDI-Public: 04953170307690
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2005
• 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