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	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts to retrieve additional information from the customer are in progress.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and the results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the evis exera iii colonovideoscope tested positive for an unexpected contamination.The positive test occurred during validation for an endoscope reprocessor.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.The following defects were noted: - flexibility adjustment ring has a scratch.- switch box has a scratch.- right / left knob has a scratch.- up / down knob has a scratch.- due to wear of angle wire, the play of up / down knob is out of the standard value.- due to wear of angle wire, bending angle in up direction does not meet the standard value.- distal end cap cover has a scratch.- adhesive on bending section rubber is detached.However, these defects alone are not considered severe enough to cause a potential adverse 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 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.
Additional Manufacturer Narrative
This report is being supplemented to provide cleaning, disinfection, and sterilization (cds) information.The cds was performed by the customer.There was no patient infection.Pre-cleaning was completed immediately after the procedure and involved the following steps: aspiration of water through the instrument/suction channel with a suction pump and flushing the air/water channel with air and water using the adapter.The scope was presoaked for an hour and passed a leak test.Bomix plus was used as the detergent for manual cleaning.The instrument/suction channel, suction cylinder, and instrument channel port were brushed during manual cleaning.Manual disinfection was not done.An olympus etd mini endoscope reprocessor was used with endodet pro as the detergent and endodis pro mit as the disinfectant.All channels were connected with tubes when setting up the reprocessor, the concentration and expiration date of the disinfectant was controlled, and the water quality of the rinse water was controlled.The customer noted the water filter was not replaced periodically in accordance with the ifu and the water used for cleaning and disinfection was not softened due to a defect in the water treatment.This lead to insufficient treatment performance.After repairing the softening, the subsequent reprocessing was successful.The scope was dried compressed air and stored in a simple cabinet.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

• 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: 17244417
• Report Number: 9610595-2023-09608
• Device Sequence Number: 15163590
• Product Code: FDF
• UDI-Device Identifier: 04953170416132
• UDI-Public: 04953170416132
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2023

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 08/07/2023
• Initial Report FDA Received Date: 07/02/2023
• Supplement Report FDA Received Date: 07/24/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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