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

Model Number	GIF-N180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus.Prior to the device being evaluated, it was sent to an independent laboratory for culture testing.The device tested positive for < 1 colony forming units (cfus) of unspecified revivable microorganisms which, is conforming to standard.The customer has not provided the cleaning sterilization and disinfection (cds) processes performed at the user facility however, this information has been requested.During the device evaluation it was uncovered that the glue of the bending section cover had discoloration and was separated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the evis exera ii gastrointestinal videoscope tested positive for unexpected contamination.The scope was sampled once.During the sampling, the scope tested positive for > 80 colony forming units (cfus) of escherichia coli.The issue was found at reprocessing during a routine culture of the scope.All channels were tested.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 legal manufacturer's final investigation and device evaluation.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
The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer confirmed that the facility does not delay the start of precleaning on the equipment after use.The customer did not provide the specific steps taken during the pre-cleaning and manual cleaning process.For automated endoscope reprocessor (aer) treatment, a s3 et wd440 machine is used with anios et detergent and soluscope p/ endo high (disinfectant).The scope is dried using towel/paper, then blown dried using filtered compressed air.The scope is stored in a plasma typhoon storage.The customer confirmed that all channels were connected with tubes when the endoscope was setting into the aer.The customer confirmed that the concentration and expiration date of the disinfectant was controlled.The customer confirmed that the water quality of the rinse water was controlled and filtered.The customer confirmed that the water filter was replaced periodically in accordance with the instructions for use (ifu).The investigation is ongoing.A final report will be submitted upon completion of the investigation.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• 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: 17907404
• Report Number: 9610595-2023-14898
• Device Sequence Number: 8225107
• Product Code: FDS
• UDI-Device Identifier: 04953170307508
• UDI-Public: 04953170307508
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2023

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: GIF-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 12/25/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/27/2023; 12/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2013
• 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