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

Model Number	PCF-HQ190I
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the colonovideoscope tested positive for an unexpected contamination.It was noted that the device was contaminated even after two rounds of disinfection.The issue was found during reprocessing.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow-up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer additionally reported following positive cultures detected: 150 cfu citrobacter koseri.300 cfu e.Coli, citrobacter koseri.After enziqure treatment: 60 cfu acinetobacter ursingii, pseudomonas aeruginosa after 2nd enziqure treatment: 150 cfu citrobacter freudii, stenotrophomonas maltophilia device sampling locations were not reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu:9cfu.Bacterial identification: bacillaceae.The customer provided the cds processes were reviewed and no obvious deviations from instructions for use (ifu) were identified.The device was evaluated and no abnormalities were found that may have led to the reported event.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, a definitive root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing, when olympus culture tested after reprocessing in accordance with the ifu before repair, the results obtained were in accordance with the regulation's alert level recommendation.It is noted that considering the nature (non-pathogenic flora) and the number of microorganisms isolated, the microbiological quality of the endoscope can be considered satisfactory for an endoscope subjected to intermediate level disinfection and rinsed with bacteriologically controlled water.The following is included in the device ifu: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 19719412
• Report Number: 9610595-2024-13804
• Device Sequence Number: 15462167
• Product Code: FDF
• UDI-Device Identifier: 04953170416132
• UDI-Public: 04953170416132
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K192793
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: PCF-HQ190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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