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
Event or Problem Description
Customer reported with an issue of "pinhole".The issue found during an unknown event.There was no patient harm, no user injury reported.Device evaluation found the coating of the insertion section is peeling off., has come off (1mm2 or more).This report is being submitted for peeling of the coating material of the insertion section found on device evaluation.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation and inspection, service repair noted the following findings: water tightness is not maintained due to perforation of the forceps channel due to external factors.Watertightness is not maintained due to holes in the curved rubber due to external factors.There is some liquid leakage from the operation part due to handling.In addition, service repair noted the coating of the insertion section is peeling off , has come off (1mm2 or more).Furthermore, the following findings during inspection were noted on the device: there are stains on the image guide (ig) bundle due to external factors.The flexible tube of the insertion section found crushed due to external factors.Scratches are found on the operation part due to external factors.There are scratches on the digital camera monitor due to external factors.The digital camera part found cracked due to external factors.The curved rubber adhesive part is missing.Liquid leakage from the operation part cover found and noted to be due to handling.Scratches on the operation unit cover due to external factors are observed.Scratches are found on the grip due to external factors.There is some liquid leakage from the grip due to handling.Liquid leakage from the up/down (ud) plate noted.Scratches are found on the angle lever due to external factors.Evaluation findings found perforation of the forceps channel and holes on the curved rubber part of the device.The customer reported issue of pinhole was confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the stress of repeated use, external factors, or handling.It is recommended that the user facility maintain a pre-use check as well as a periodic check of the device.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15285602
• Report Number: 9610595-2022-01264
• Device Sequence Number: 2278839
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: Other
• 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
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2016
• 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