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
The customer reported the airway mobilescope had air/water leakages.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the coating of the connecting tube was peeled.The report is being submitted due to the peeled coating found during evaluation.
Additional Manufacturer Narrative
Full name in e1: (b)(6)hospital.Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the complaint was confirmed and water tightness was lost due to a crack on the control unit, a pinhole on the instrument tube, and pinching of the bending section cover.Also, evaluation found the bending section cover had slack, the bending section cover adhesive was chipped, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the connecting tube was dented, and multiple parts of the scope were scratched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.The device was noted to be previously repaired in august 2021.Although a definitive root cause of the defect could not be identified, it was determined that stress of repeated use, external factors or handling likely caused the peeled coating.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16816631
• Report Number: 9610595-2023-06735
• Device Sequence Number: 14873588
• 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): 04/26/2023

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-GM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2016
• 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