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

Model Number	GIF-N180
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); 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 for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that there was foreign dark grey jelly material with some synthetic fibers clogging the nozzle and could not be removed.This finding was due to accumulation and clogged the nozzle during reprocessing.Upon further observation, it was observed that the adhesive of the bending section cover had a gap.It was also observed that the lenses glues were worn out.It was observed that the insertion tube wrinkled near the glue.It was also observed that the bending angulation did not meet specifications.It was observed that key top 1 showed signed of wear and tear.Lastly, it was observed that the mouthpiece pins had an air leak.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 had clogged channels.There was no patient/user harm or injury reported due to the event.
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 root cause of the event was unable to be identified.The dark gray jelly/synthetic fiber on nozzle was unable to be identified.There was physical damage at foreign object detection point and there were no obvious deviations in reprocessing.The event can be detected by following the instructions for use which state: "inspection of the endoscopic system - inspection of the air-feeding function." 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: 16138089
• Report Number: 9610595-2023-00601
• Device Sequence Number: 6817098
• 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): Unknown
• 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): 03/30/2023

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: 12/16/2022
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2010
• 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