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
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The customer allegation was confirmed.Due to wear of angle wire, bending angle in up direction did not meet the standard value.In addition to the malfunction documented in b5, the additional evaluation findings are as follows; water tightness was lost due to a pinhole on channel tube and damage on camera section, the bending section cover (black covering of the bending section) had a scratch, the adhesive on the bending section cover (black covering of the bending section) had a chip, the angulation lever did not move smoothly due to damage on the control section, the control unit had a scratch, the camera section had a scratch, the grip had a scratch, the up/down angulation lever plate had a scratch, the angulation lever had a scratch and the scope cover had a scratch.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus, the airway mobilescope could not angulate sufficiently.The device was returned for evaluation.During the device evaluation, it was observed that the coating of the image guide pipe was peeling off (1 millimeter (mm) to 2mm or more).There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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 of the event was unable to be identified.The event likely occurred due to stress from use, external factors, or handling.The inspection method for this event is described in the instruction manual (operation edition) "chapter 3 preparation and inspection 3.6 inspection of the endoscope" as follows: "endoscope inspection 4.Visually check that there are no bends, twists, bulges, or other abnormalities near the boundary between the ore-dome part and the insertion part.5.Cracks, dents, bulges, edges, scratches, protruding metal wires, protrusions, sagging, deformation, bending, adhesion of foreign matter, falling parts, etc.On the outer surface of the entire length of the insertion tube, including the curved part and tip.Visually check that there are no abnormalities.6.Gently grip the insertion tube with your hand and slide it along the entire length in both directions, making sure that there are no snags or metal wires protruding from the inside around the entire circumference.Also, check by feeling that the soft parts are not abnormally hard." 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: 18167323
• Report Number: 9610595-2023-17659
• Device Sequence Number: 6061328
• 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): 12/20/2023

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: 10/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2009
• 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