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

Model Number	CF-H180DI
Medical Device Problem Code	Device Reprocessing Problem (1091)
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 that during the device evaluation, the air/water tube, cylinder and jet tub had foreign objects on the videoscope.There were no reports of 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 investigations, residual whitish foreign material was found inside the a/w-cylinder, a/w-channel, and auxiliary water channel.Therefore, the device did not meet its specifications and function.It could not be specified what the foreign material was nor the root cause of the remaining foreign material.The foreign material may not have been removed since the reprocessing was not conducted properly per instructions for use (ifu).Additional information stated that the scope was not disinfected after field service inspection.It was confirmed that the section of the device with the foreign material residue had no deformation.Performance of reprocessing on the device was secured in the reports by reprocessing appropriately in accordance with instructions for use (ifu/cleaning/disinfection/sterilization).There was no report that the device was used for procedure while the event occurred.The suggested events can be detected and prevented by handling the device in accordance with the following instructions for use (ifu): ifu states the detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection; ifu states the preventative measures in 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: 19002873
• Report Number: 9610595-2024-06504
• Device Sequence Number: 9429437
• Product Code: FDF
• UDI-Device Identifier: 04953170339639
• UDI-Public: 04953170339639
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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-H180DI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2012
• 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