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

Model Number	MAF-GM2
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that the airway mobilescope had an air/water leakage.There was no report of patient harm.The device was returned for evaluation.During the device evaluation, it was found connecting tube had coating peeling.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: due to a pinhole on connecting tube, water tightness was lost, due to wear of angle wire, bending angle in up direction did not meet the standard value, camera section was damaged, due to damage on the image guide bundle, the image had a stain, and connecting tube had a dent.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.
Additional Manufacturer Narrative
This report is being supplemented 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.Based on the results of the investigation, it is likely the defect was caused by stress of repeated use, external factors, or handling of the device.Instructions, operation manual chapter 3 ¿preparation and operation¿ section 3.6 ¿inspection of the endoscope¿ describes how to inspect for the event as below: "3.Inspect the boot and the insertion section near the boot for any irregularities such as bends, twists, tears, and cracks.4.Inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.5.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section.Confirm that no objects hindering transnasal insertion and withdrawal or metallic wire protrude from the insertion section.Also, confirm that the insertion tube is not abnormally rigid." 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: 18238136
• Report Number: 9610595-2023-18398
• Device Sequence Number: 3201438
• Product Code: EOQ
• UDI-Device Identifier: 04953170407208
• UDI-Public: 04953170407208
• 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): 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): 12/12/2023

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-GM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown