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

Model Number	MAF-DM2
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
The device was returned to olympus for evaluation and the customer's allegation of a defect of the connecting tube was confirmed, however, the allegation of a broken fiber was not confirmed.The device evaluation found the insertion part of the soft tube coating was peeling off.In addition, the evaluation found the following; due to a pinhole on the bending section cover, water tightness was lost.The adhesive on the bending section cover had a chip.Due to wear of the angle wire, the bending angle, in the up direction, did not meet the standard value.Due to a dent on the channel tube, the channel cleaning brush could not be inserted smoothly.The battery slot had corrosion, due to water leakage, the power button did not function due to damage, and due to damage on the digital camera, the power turns on unintentionally.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
It was observed that during the device evaluation, the airway mobilescope exhibited the insertion part of the soft tube coating was peeling off.There were no reports of patient involvement.
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 of the device.It was confirmed that instructions, chapter 3 ¿preparation and inspection¿, section 3.6 ¿inspection of the endoscope¿ describes how to inspect for the subject event.It is suggested that the user facility review the method of device handling according to the instructions for use (ifu).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: 18624247
• Report Number: 9610595-2024-02212
• Device Sequence Number: 20750197
• Product Code: EOQ
• UDI-Device Identifier: 04953170407260
• UDI-Public: 04953170407260
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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-DM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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