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

Model Number	GIF-XP150N
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for physical evaluation.A device history review revealed no issues that could have caused or contributed to the reported issue.It has been over 9 years since the device was manufactured.While the device was not returned, it was confirmed that the gastrointestinal videoscope was reprocessed in an endoscope reprocessor which did not have its water filter replaced at the recommended monthly time period.The water filter failed to have been replaced in accordance with a frequency of at least once a month, which is recommended in the instruction manual.This issue is addressed in the instructions for use (ifu): regarding instructions, operation manual for oer-3 chapter 7 ¿routine maintenance¿ section 7.2, replacing the water filter (maj-2317).Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus, the gastrointestinal videoscope was used with a olympus endoscope reprocessor that received an e01 error code (filling the basin with water took too long).The facility confirmed that the water filter had not been replaced in over a month.There were no reports of patient harm.This report is linked to the patient identifier (b)(6).
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.The cause for the foreign material remaining in the device was attributed to the customer not changing the water filter per the instructions for use (ifu).The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) ifu chapter 7 ¿routine maintenance¿ section 7.2 ¿replacing the water filter¿.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18108085
• Report Number: 9610595-2023-16881
• Device Sequence Number: 5698187
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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-XP150N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COLONOVIDEOSCOPE; GASTROINTESTINAL VIDEOSCOPE; OLYMPUS ENDOSCOPE REPROCESSOR
• Patient Sex: Unknown