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

Model Number	PCF-H190I
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during reprocessing, the colonovideoscope tested positive for 23 colony forming units (cfus) of pseudomonas aeruginosa and pseudomonas hominis.The suction channel tested positive for 21 cfus of pseudomonas hominis, and the axillary channel tested positive for 1 cfu of pseudomonas aeruginosa.All channels were sampled.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 device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the lms final investigation.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: jun 11, 2024.Sampling from: all channels.Cfu: <1 cfu/endoscope (<1 cfu/100ml).Bacterial identification: n/a.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, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the ifu before repair, it resulted in detection of bacteria.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that, during reprocessing, the colonovideoscope tested positive for greater than 100 colony forming units (cfus) of citrobacter freundii and pseudomonas aeruginosa in the biopsy channel, greater than 100 cfus of citrobacter freundii in the suction channel, 1 cfu of the citrobacter freundii in the air/water channel, 50 cfus of citrobacter freundii and pseudomonas aeruginosa in the auxiliary water channel, greater than 100 cfus of citrobacter freundii, and greater than 100 cfus of pseudomonas aeruginosa in the entire scope.A second test was performed three days later and tested positive for greater than 100 cfus of pseudomonas aeruginosa in the suction channel, 2 cfus of the citrobacter freundii in the air/water channel, 5 cfus of the citrobacter freundii and pseudomonas aeruginosa in the auxiliary water channel, and greater than 100 cfus of pseudomonas aeruginosa in the entire scope.A third test was performed four days later and tested positive for 21 cfus of pseudomonas aeruginosa in the suction channel, 1 cfu of the staphylococcus hominis in the air/water channel, 1 cfus of pseudomonas aeruginosa in the auxiliary water channel, and greater 23 cfus of pseudomonas aeruginosa in the entire scope.All channels were sampled.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.

• 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: 19538283
• Report Number: 9610595-2024-12037
• Device Sequence Number: 6425040
• Product Code: FDF
• UDI-Device Identifier: 04953170436673
• UDI-Public: 04953170436673
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131780
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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