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

Model Number	CF-2T160L
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 was returned for evaluation.Upon estimation it was discovered there was foreign matter found within the nozzle.This was due to insufficient cleaning.The following issues were found during the device evaluation: (a.) bending manipulation or angulation was reduced as the angle wires were stretched, (b.) surface defects of the universal cord were identified.The coating was peeling off, (c.) the distal end of the universal cord had cracks in the resin, (d.) there was deterioration or discoloration of the control body, (e.) the resin in the air and water was cracked causing leakage from the body control unit, (f.) parts become loose in the air and water channel or body control unit, (g.) and the watertight area was defective and had fluid invasion.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The evis exera colonovideoscope was returned to an olympus service center for annual maintenance with no complaint reported by the end user.During inspection, it was discovered there was foreign matter found within the nozzle.There was no patient involvement.This report is being submitted for the malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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, the root cause of the event was unable to be identified.The white foreign body appeared to be a residue from a previous case.No physical damage to air/water cylinders (internal) or air/water tubes was reported.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 17307834
• Report Number: 9610595-2023-10012
• Device Sequence Number: 17922275
• Product Code: FDF
• UDI-Device Identifier: 04953170066986
• UDI-Public: 04953170066986
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954451
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: CF-2T160L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2006
• 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