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

Model Number	MAF-TM2
Medical Device Problem Codes	Contamination (1120); 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.It has been over 2 years since the subject device was manufactured.The device was returned to olympus.The customer¿s allegation of the power cannot be turned on could not be confirmed.However, due to deterioration the connecting tube had coating peeling.During the device evaluation, the following was found: the bending section cover (a-rubber) had slack.The adhesive on the bending section cover (a-rubber had a chip.The connecting tube had a wrinkle.Due to wear of the angle wire, bending angle in the up direction did not meet the standard value.The battery slot was dirty due to water leakage.The control unit had a scratch.The camera section had a scratch.Due to damage on the digital camera.The recording mode button did not function due to damage.The grip had a scratch.The camera section had a scratch.Due to damage on the digital camera, image noise occurred.The recording mode button did not function due to damage.Based on the investigation, the adhesive was peeling likely due to stress from repeated use, reprocessing, external factors, and handling of the device over time.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the airway mobilescope power could not be turned on.There is no report of patient or user harm associated with the event.During inspection and testing of the returned device, it was discovered that the coating on the connecting tube was peeling.This report is being submitted to capture the reportable malfunction which was identified during the evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation.Updated b5.
Event or Problem Description
Upon inspection of the device, foreign matter was found coming out from the insertion section.The event was identified during testing and inspection of the returned device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's reinvestigation.Based on the results of the reinvestigation, the root cause of the foreign material could not be concluded although component analysis detected a component derived from chemicals that did not originate from the endoscope nor the manufacturing of the endoscope (a component which was included in mepivacaine hydrochloride).Therefore, chemicals may have remained on the surface of the insertion section, but the root cause of the foreign material remaining was unable to be specified.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: 17654714
• Report Number: 9610595-2023-12484
• Device Sequence Number: 7278662
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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: 08/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 10/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/18/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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
• Patient Sex: Unknown