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

Model Number	GIF-1TH190
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the evaluation found no malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the gastrointestinal videoscope exhibited the nozzle blocked by foreign material.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction: (d5- operator of device) should be: other & olympus.Correction: (g2 ¿ report source) should be: company representative.Correction: (g3 ¿ date received by manufacturer) should be: 09/02/2024.Correction: (h6 - component code) also need to include: 525 - tube.Correction: (h6 - impact code) should be: no patient involvement.New information added to the following fields: h6.A review of the device history record found there were no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.Based on the investigation results, clogged foreign material in the nozzle & clogged air/water channel, could not be identified.The legal manufacturer confirmed there was no deviation from the reprocessing steps.Regarding the foreign material, we could confirm the clogging of the material in the nozzle; however, we could not identify the material.The foreign material was possibly not removed since the reprocessing was not conducted properly due to leakage from connector and scope cover.Leakage occurred from connector and scope cover.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿ifu states that detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.¿ olympus will continue to monitor the 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: 20238339
• Report Number: 9610595-2024-18532
• Device Sequence Number: 20999375
• Product Code: FDS
• UDI-Device Identifier: 04953170437014
• UDI-Public: 04953170437014
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K232997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown