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

Model Number	CF-HQ190I
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 during the olympus device evaluation, the colonovideoscope exhibited white foreign material on the jet tube.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus and evaluated.Besides the reportable malfunction of foreign material in the jet tube additionally, the evaluation found the following non-reportable malfunction(s): aw-cylinder and suction cylinder had no color; due to wear of angle wire, bending angle in up direction did not meet the standard value; due to a crack, probe cover had a snag on it; adhesive on bending section cover was detached; connecting tube had a scratch; universal cord had a scratch.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.It has been over 6 years since the subject device was manufactured.   based on the results of the investigation, it could not be definitively determined what the foreign material was adhered/clogged in auxiliary water channel.There was no damage to the area where the foreign material was detected and it is unknown if reprocessing was conducted in accordance with instructions for use.Therefore, the cause of the material remaining in the device could not be determined.The suggested event is detectable/preventable by handling the device in accordance with the following instructions for use.Instructions for use states the detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Instructions for use states the preventative measures 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: 18638586
• Report Number: 9610595-2024-02394
• Device Sequence Number: 20815932
• Product Code: FDF
• UDI-Device Identifier: 04953170416132
• UDI-Public: 04953170416132
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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-HQ190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2018
• 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