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

Model Number	GIF-E3
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.In addition to foreign material found to be clogging the nozzle, the following events were also found: damage to the distal end, the light guide cover lens was cracked, the image guide cover glasses were scratched, the adhesive on the bending section cover was porous, the bending tube was deformed, the connecting tube was scratched, the scope cover and body were both scratched, the paint on the air/water nut was peeling off, the paint on the suction cylinder nut was peeling off, the universal cord was scratched, the diopter ring was scratched, the ring was scratched, the lens was humid, the cover glass was scratched, the right/left-up/down knob had angulation play and was less than specified value, the up/down knob was broken as there was no brake engagement during angulation, there were fiber breakings on the image guide bundle, and there was a problem with the sunction function (26,7 kpa) to specify suction flow (ml/min; 550).Regarding the clogging of the nozzle, this impacted the component¿s water flow, air/water function and static.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
The customer reported to olympus that the working channel was blocked on the gastrointestinal fiberscope.The issue occurred during reprocessing and there was no patient harm associated with the event.The device was returned and evaluated, and the nozzle was found to be clogged with foreign material.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 foreign material could not be determined.The material could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL FIBERSCOPE
• Common Device Name: GASTROINTESTINAL FIBERSCOPE
• 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: 15950011
• Report Number: 9610595-2022-05180
• Device Sequence Number: 17998721
• Product Code: FDS
• UDI-Device Identifier: 04953170307355
• UDI-Public: 04953170307355
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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-E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 03/11/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2018
• 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