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

Model Number	MAF-GM
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
A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely the coating peeled off due to a usage stress, external factors, or handling.However, a definitive root cause could not be determined.During inspection and testing, the reported issue (pinhole on bending section cover) was confirmed and found to be caused by external factors.It was observed there a leakage due to a pinhole.In addition, service found the insertion tube was crushed due to external factors.There was a leakage from the digital camera, and the cross/ok/menu buttons due to external factors.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported there was a pinhole on the bending section cover of the subject device.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the coating on the insertion tube was peeling off.This report is being submitted for the malfunction found during evaluation (coating peeling off).Additional details were requested regarding the reported event; however, no further information was available.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15290134
• Report Number: 9610595-2022-01279
• Device Sequence Number: 16717324
• Product Code: EOQ
• UDI-Device Identifier: 04953170340369
• UDI-Public: 04953170340369
• 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): 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): 08/24/2022

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-GM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2016
• 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