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

Model Number	CF-H180AL
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The customer reported the endoscope was incorrectly reprocessed.The scope was reprocessed using an endoscope reprocessor, where the internal air and water filters had not been replaced since the date of install.There were no reports of patient harm.
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.It has been over fourteen (14) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that improperly reprocessed device was used in a procedure was due to e user did not read instructions for use carefully, incorrectly managed water filter replacement and used the filter even after its replacement period has expired.The event can be detected/prevented by following the instructions for use which state: oer-elite.Chapter 8 replacement of consumable items -8.4 replacing the water filter (maj-824 or maj-2318) -to prevent contamination of the rinse water, the water filter should be replaced every month when the prefilter is not used or every six months when the prefilter is used.-warning ·replace the water filter at least every month when the prefilter is not used or every six months when the prefilter is used.If the water filter is not replaced regularly, the performance of the water filter drops, and insufficient elimination of microorganisms in the water may cause contamination of the reprocessor piping.As a result, the reprocessing of endoscopes will be insufficient.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: 18849950
• Report Number: 9610595-2024-04781
• Device Sequence Number: 20715958
• Product Code: FDF
• UDI-Device Identifier: 04953170202445
• UDI-Public: 04953170202445
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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-H180AL
• Was Device Available for Evaluation?: Yes
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OER -ELITE (ENDOSCOPE REPROCESSOR); OER -ELITE (ENDOSCOPE REPROCESSOR)
• Patient Sex: Unknown