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

Model Number	GIF-XP190N
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When the foreign material was identified, olympus requested additional information from the customer on their reprocessing practices.The customer reported the device was cleaned, disinfected, and sterilized before it was sent in for repair.The customer could not identify the source of the foreign material.According to the customer, there was no delay in the start of the pre-cleaning and the air/water nozzle was flushed with air and water.The customer reported that prior to manual processing, the device was presoaked in detergent solution.During manual cleaning, there were no abnormalities in the reprocessing accessories, the nozzle was wiped with lint-free cloths/brushes/sponges and the air/water nozzle was flushed with detergent solution.During evaluation, the reported issue (blockage) was confirmed; the nozzle was clogged with foreign material.This caused the device to fail the air/water flow testing.Functional testing showed the device's directional knobs tested within specifications but replacement was recommended due to minor play in the knobs.The device was visually examined.During examination, the following issues were found: the insertion tube was dented at the 22 cm mark; and the bending section cover adhesive was cracked.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus that the gastrointestinal videoscope caused the medivator to keep saying there was an air channel block.The device was returned to olympus for evaluation.During evaluation, foreign material was found at the air/water nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.The issue was found during scope reprocessing.No patient involvement reported.
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 was unable to be identified and the root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu): ifu states the detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection ifu states the preventative measures in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18140963
• Report Number: 9610595-2023-17260
• Device Sequence Number: 6467209
• Product Code: FDS
• UDI-Device Identifier: 04953170436772
• UDI-Public: 04953170436772
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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-XP190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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: MEDIVATOR AUTOMATED ENDOSCOPE REPROCESSOR.
• Patient Sex: Unknown