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

Model Number	CF-Q160ZL
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, that the olympus endoscope reprocessor (oer) was used to improperly reprocess the colonovideoscope with an expired water filter.The water filter had not been changed since 2021, subsequently leading to the mismanagement of replacing the water filter in accordance with the instructions for use.There were no reports of patient harm, injury, or infection.Related patient identifiers: (b)(6).
Additional Manufacturer Narrative
Additional information received from the customer confirmed that a third party company provided maintenance service to the hospital's equipment.The device was not returned to olympus for evaluation.The investigation is ongoing, 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 report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Information added to the fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon was not duplicated during evaluation because the subject device was not returned.It is likely that the user did not read instructions for use (ifu) thoroughly and used the water filter after replacement limit period expired by management error for replacement.The suggested event is detectable/preventable by handling in accordance with the following instructions for use (ifu).Chapter 7 "routine maintenance" 7.2 "replacing the water filter (maj-824)" "replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 18538390
• Report Number: 9610595-2024-01157
• Device Sequence Number: 7588295
• Product Code: FDF
• UDI-Device Identifier: 04953170067495
• UDI-Public: 04953170067495
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K001241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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-Q160ZL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2010
• 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