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

Model Number	GIF-N180
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, however, evaluation for the reported event is ongoing.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the gastrointestinal videoscope had too much pressure in the air/water channel during an rhinaer treatment.There was no report of patient harm.The device was returned, evaluated, and a foreign object was in the nozzle.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's complaint was confirmed.Foreign material was found in the nozzle.In addition, the following non-reportable malfunctions were found during the device evaluation: rubber glue worn out, connecting tube wrinkled near glue, bending angulation out of specifications, air/water flow issues present.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 the foreign material was not identified.A specific root cause of the foreign materials being stuck in the nozzle could not be determined at this time.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• 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: 17849540
• Report Number: 9610595-2023-14364
• Device Sequence Number: 19696264
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• 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): 10/24/2023

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
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/01/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2012
• 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