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
During the device evaluation, the colonovideoscope exhibited white foreign material inside the auxiliary jet tube, air/water-tube, and air/water-cylinder.There were no reports of patient involvement.
Additional Manufacturer Narrative
Corrected e2, e3 and g2 with information that was inadvertently missed on the initial medwatch.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 foreign material could not be identified.It is likely the foreign material remained adhered to the device because reprocessing could not properly be performed due to water leak.There was no deviation from instructions for use in reprocessing steps for the locations where foreign material remained.No physical damage was found at the locations.The suggested events are detectable and preventable by handling 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 preventive 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: 19168764
• Report Number: 9610595-2024-08508
• Device Sequence Number: 15438313
• Product Code: FDF
• UDI-Device Identifier: 04953170339639
• UDI-Public: 04953170339639
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0329-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown