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

Model Number	CF-H180DL
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 as part of the asset return process.In addition to the jet tube being clogged due to insufficient cleaning, additional findings were as follows: air/water cylinder had no color; suction cylinder had no color; adhesive on bending section cover had a crack; due to clogging of jet tube normal water supply was not performed and water could not be supplied.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
A user facility returned the olympus asset, evis exera ii colonovideoscope, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the jet tube was clogged.This report is being submitted for the reportable malfunction found during evaluation.There was no patient involvement.
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.It was not possible to confirm any foreign matter adhering to or clogging the sub-water channel, and it was not possible to identify the foreign matter.It was confirmed that reprocessing was carried out in accordance with the instruction manual in the reprocessing procedure for areas where foreign matter remained.No physical damage was observed where foreign matter remained.The detection method is described in the instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Prevention measures are described in the instruction manual evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).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: 18483950
• Report Number: 9610595-2024-00592
• Device Sequence Number: 2820647
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K051645
• 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): 02/16/2024

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: Health Professional
• Device Model Number: CF-H180DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2014
• 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