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

Model Number	MAF-TM
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the airway mobilescope had foreign material in the forceps channel.There were no reports of patient involvement.
Additional Manufacturer Narrative
This reported is being supplemented to provide additional information obtained during the device inspection.Correction to h6 and b5: please see b5 for further information.
Event or Problem Description
Correction to b5 of the initial report: the subject device also had insertion section flexible tube coating peeled off and display disappeared.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.It has been over ten (10) years since the subject device was manufactured.Based on the results of the investigation, for the event of "foreign material in the instrument channel" it is presumed that a kink on the instrument channel resulted in insufficient brushing cleaning since the forceps getting caught occurred other than the subject event.For the events of "coating on the insertion tube of the insertion section was peeled off" and "the marking on the insertion tube of the insertion section disappeared" it is presumed that the defect was caused by stress by repeated use, external factors, or handling of the device.The events can be detected/prevented by following the instructions for use which state: event 1: a foreign material in the instrument channel it was confirmed that instructions for airway mobilescope maf-gm/tm chapter 8, ¿cleaning, disinfection, and sterilization procedures¿ section 8.6, ¿manual cleaning¿ describes how to inspect for the event.Event 2: coating on the insertion tube of the insertion section was peeled off it was confirmed that instructions for airway mobilescope maf-gm/tm chapter 3, ¿preparation and inspection¿ section 3.6, ¿inspection of the endoscope¿ describes how to inspect for the event.Event 3: the marking on the insertion tube of the insertion section disappeared it was confirmed that instructions for airway mobilescope maf-gm/tm chapter 3, ¿preparation and inspection¿ section 3.6, ¿inspection of the endoscope¿ describes how to inspect for the event.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: 20201790
• Report Number: 9610595-2024-18235
• Device Sequence Number: 20745617
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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: Other
• Device Model Number: MAF-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 09/30/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2014
• 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