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

Model Number	MAF-TM
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The evaluation found the water tightness was lost due to a pinhole on the protective coating of the bending portion of the device, the adhesive on the protective coating of the bending portion of the device was chipped, the up angulation was out of specification, the channel tube was dented, the forceps and the channel cleaning brush could not be inserted smoothly, the control unit was discolored, the camera section was scratched, the image guide bundle had breakages, the display did not move smoothly due to damage of the camera section, and the connecting tube was dented and buckling.The investigation is ongoing.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
During the device evaluation, it was observed the airway mobilescope exhibited peeling of the connecting tube coating.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted 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.The device was returned to olympus for evaluation.The customer's allegation was confirmed.Based on the results of the investigation, the device malfunction likely occurred due to usage stress, external factors, or handling.However, a definitive root cause could not be established.The event can be detected and prevented by handling the device in accordance iwth the instructions for use which state: chapter 3 preparation and inspection 3.6 endoscope inspection: -endoscope inspection "4.Visually check that there are no bends, twists, bulges, or other abnormalities near the boundary between the oredome part and the insertion part.5.Cracks, dents, bulges, edges, scratches, protruding metal wires, protrusions, sagging, deformation, bending, adhesion of foreign matter, falling parts, etc.On the outer surface of the entire length of the insertion tube, including the curved part and tip.Visually check that there are no abnormalities.6.Gently grasp the insertion tube with your hand and slide it along its entire length in both directions, making sure that there are no snags or metal wires protruding from inside around the entire circumference.Also, check by feeling that the soft parts are not abnormally hard." 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: 18615876
• Report Number: 9610595-2024-02123
• Device Sequence Number: 16736546
• Product Code: EOQ
• UDI-Device Identifier: 04953170288630
• UDI-Public: 04953170288630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082720
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2024

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: MAF-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2014
• 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
• Patient Sex: Unknown