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

Model Number	MAF-TM2
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: due to a cut on the connecting tube; water tightness was lost.The adhesive on the distal sheath had a chip, and due to wear of the angle wire; bending angle in the up direction did not meet the standard value.Device history records: the device history records for this device were reviewed, and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Complaint history review: there was no complaint of the same or similar event as the reported event at the same facility and same device.However, a similar complaint, (b)(4), was initiated from another facility for the same device, and a similar complaint.Conclusion: the root cause could not be identified.The issue was likely to have been caused by stress, external factors, or handling.It is recommended to the user to inspect prior to use.And on a regular basis continuously inspection of the entire endoscoperotate, the digital camera section and adjust the angle of the lcd monitor slowly until it stops in each direction.And make sure that it moves smoothly without any abnormalities such as roughness and snagging of operation, can be fixed in any position, and does not rotate carelessly.The appearance of the control part is visually and hand-checked to ensure that there are no abnormalities such as large scratches, deformation, or loose parts.Visually check that there are no abnormalities such as bending, twisting, swelling, cutting, chipping, etc.Near the boundary between the oredome part and the insertion part.Visually check that there are no cracks, dents, bulges, edges, scratches, peeling of cladding members, protrusions, sagging, deformation, bending, adhesion of foreign matter, falling off of parts, or other abnormalities on the outer surface of the entire length of the insertion part, including the curved part and the tip.Grab the insertion part lightly with your hand and slide it in both directions along the entire length.And check with your hand that there are no snags or protruding metal wires from the inside around the entire circumference.Also, check with your hand that the soft part is not abnormally hard.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The olympus representative reported (on behalf of the customer), that the coating on the airway mobilescope insertion section was peeling off.The coating detachment was noticed during the endotracheal check.The intended tracheal intubation for anesthesia, during the laryngoscopic malignant laryngeal tumorectomy procedure, was completed by checking the inside of the trachea with a fiber.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted, that the image guide snake tube coating was peeled.This report is to capture the reportable malfunction of the image guide coating that was peeled off and noted at estimation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16795454
• Report Number: 9610595-2023-06596
• Device Sequence Number: 6377707
• Product Code: EOQ
• UDI-Device Identifier: 04953170407147
• UDI-Public: 04953170407147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: MAF-TM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• 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