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

Model Number	GIF-XTQ160
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the evis exera gastrointestinal videoscope tested positive for an unexpected contamination on the swab of the distal end.The issue was found during a routine culture of the scope.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
To date, the device has not been returned to olympus for evaluation as the user facility has stated that the device is under quarantine.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, because the user culture results and reprocessing method were not shared and because the subject device was not returned, a root cause could not be determined.The reported event was not confirmed as the scope was not microbiologically tested by olympus the instructions for use (ifu) provide the following warning: "all channels of the endoscope, including auxiliary water channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 17471240
• Report Number: 9610595-2023-11240
• Device Sequence Number: 19511023
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K011151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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-XTQ160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2009
• 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