MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIRWAY MOBILESCOPE

Model Number	MAF-GM2
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-0000436.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a therapeutic lung resection procedure, using airway mobilescope, there was no moving image on the screen and bad quality image was produced.No error message was produced.The procedure was reported to be extended for 1 hour while the patient was sedated, and the procedure tried on a backup olympus scope with a (different model was used) that gave a pixelated image.The procedure was completed without any impact to the patient.The patient is reported to be doing fine.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (d9) and to provide an update to fields (h3 and h4).The device was evaluated by olympus, and the liquid crystal display (lcd) panel required fluid invasion.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, it is likely that the reported event occurred due to the internal circuit of the liquid crystal display (lcd) panel shorted-out with water invasion.Although the observed device defect is a non-reportable malfunction, the component failure likely caused and/or contributed to the reported adverse event (procedure was delayed).However, the specific root cause could not be specified.The event can be detected/prevented by following the instructions for use which state: "reprocessing the endoscope (and related reprocessing accessories)", "leakage testing of the endoscope", " perform the leakage test".Olympus will continue to monitor field performance for this device.

• Brand Name: AIRWAY MOBILESCOPE
• Common Device Name: AIRWAY MOBILESCOPE
• 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: 20417695
• Report Number: 9610595-2024-20616
• Device Sequence Number: 18207257
• Product Code: EOQ
• UDI-Device Identifier: 04953170407208
• UDI-Public: 04953170407208
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAF-GM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown