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

Model Number	GIF-XTQ160
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus and evaluated.In addition to the reportable malfunction of foreign material (non-olympus plastic valve) stuck within the insufflation cylinder, the evaluation found non-reportable device malfunctions/conditions.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was observed during the olympus device evaluation, the videoscope had a foreign material (non-olympus plastic valve) stuck within the insufflation cylinder.There were no reports of patient involvement.
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, the foreign material could not be identified nor the root cause of it.The events can be detected/prevented in accordance with the following instructions for use: operation manual chapter 3 preparation and inspection.Reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.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: 18867066
• Report Number: 9610595-2024-05061
• Device Sequence Number: 19661708
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K011151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: GIF-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2017
• 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