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

Model Number	MAF-TM
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 initially reported to olympus that the airway mobilescope had pinholes.There were no reports of patient harm.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: the indication on connecting tube had a disappeared area (1mm squared or more).
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was confirmed; due to a pinhole in the bending section cover, water tightness was lost and due to damage on the camera section water tightness was lost.In addition to the indication on the connection tube disappeared area, the evaluation findings were as follows: due to wear of the angle wire, bending angle in the "up" direction did not meet standard value, and abnormal sound was made due to damage on the angulation lever, the control unit was sticky due to water leakage, the scope cover was sticky due to water leakage, the image guide bundle had significant breakages, and the connecting tube had a dent and scratch.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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, the root cause could not be determined.It is likely the event was caused by stress from repeated use, external factors, or handling.The following information from the instructions for use (ifu) pertains to this event: "1.Inspect the control section and the camera section for excessive scratching, deformation, loose parts, or other irregularities.2.Confirm that the instrument channel port does not rotate or turn by attempting to rotate or turn the instrument channel port in a counterclockwise direction as shown in figure 3.21.If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to olympus for repair.6.Holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section (see figure 3.23).Confirm that no objects or metallic wire protrudes from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.7.Inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.8.Using both hands, bend the insertion tube into a semicircle.By moving your hands as shown by the arrows, confirm that the entire insertion tube can be smoothly bent to form a semicircle (see figure 3.24)." 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: 17966649
• Report Number: 9610595-2023-15504
• Device Sequence Number: 6800205
• Product Code: EOQ
• UDI-Device Identifier: 04953170288630
• UDI-Public: 04953170288630
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2010
• 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