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

Model Number	PCF-H180AI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The physical device evaluation has not yet been completed.The customer provided their cleaning, disinfection, and sterilization process.The detergent used for pre-cleaning is aniosyme x3.Life partners europe is the bedside pre-cleaning practice for endoscope at user facility.The scopes are manually cleaned using aniosyme x3 and manually disinfected using autre.The biopsy valve, the air valve, and the suction valve are disinfected or sterilized automatically.The automated endoscope reprocessor (aer) used is a soluscope 4 (non-olympus), using soluscope cln detergent, and soluscope paa disinfectant.Scopes are stored in esset soluscope.Olympus is the maintenance company for the scope.After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured.One (1) colony forming unit (cfu) coagulase-negative staphylococci were identified.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
The customer reported to olympus that during routine testing, the endoscope tested positive for microbial contamination.On (b)(6) 2022, all channels were sampled and tested positive for greater than 25 colony forming units (cfu) of pseudomonas aeruginosa.On (b)(6) 2022, all channels were sampled and tested positive for greater than 25 colony forming units (cfu) of germs (raoultella planticola: 8 cfu, citrobacter freundii: 1 cfu, and pseudomonas aeruginosa: 14 cfu).The user did not report any contamination or any other serious deterioration in the 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 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.A few defects were noted where the bending section rubber glue was separated, the channel mount was damaged, the coil pipe plate was deformed, the key top 1 had an unclear indication, and the angulations were less than the specified value.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 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15538053
• Report Number: 9610595-2022-02553
• Device Sequence Number: 17903997
• Product Code: FDF
• UDI-Device Identifier: 04953170339875
• UDI-Public: 04953170339875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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-H180AI
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2014
• 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