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

Model Number	PCF-H180AL
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Prior to the device evaluation, olympus sent out the device for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and microbial of >20 colony forming units (cfu) of enterococcus faecium in the air/water channel and 12 cfu of enterococcus faecalis/ enterococcus faecium in the auxiliary water channel were detected.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported that the colonovideoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.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
This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation and the legal manufacture¿s final investigation.Despite good faith attempts the user culture results and cleaning disinfection and sterilization (cds) processes were not shared.The lm reviewed the customer provided cds processes where information to judge deviation from the instructions for use (ifu) was not identified.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: jun 06, 2024.Sampling from: a/w-channel.Cfu: >20cfu/ml(37¿).Bacterial identification: enterococcus faecium.Sampling from: auxiliary water channel.Cfu: 12cfu/ml(37¿).Bacterial identification: enterococcus faecalis, enterococcus faecium.Olympus reprocessed the subject device according to the instructions for use (ifu) and re-culture tested where the results were: sampling date: jun 13, 2024.Sampling from: distal end.Cfu: n.D.Bacterial identification: no detection.Sampling from: biopsy channel/suction channel.Cfu: 0cfu/ml(37¿).Bacterial identification: no detection.Sampling from: a/w-channel.Cfu: 0cfu/ml(37¿).Bacterial identification: no detection.Sampling from: auxiliary water channel.Cfu: 0cfu/ml(37¿).Bacterial identification: no detection the device was evaluated where no abnormalities were found that could 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 and because the user culture results were not shared, the reported event could not be confirmed, and a root cause could not be determined.Growth of microorganisms were reported through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.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 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: 19566843
• Report Number: 9610595-2024-12327
• Device Sequence Number: 6974886
• Product Code: FDF
• UDI-Device Identifier: 04953170237287
• UDI-Public: 04953170237287
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: PCF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• 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: 06/02/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2010
• 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