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

Model Number	MAF-TM2
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the airway mobilescope had a crushed insertion part.There were no reports of patient or user harm associated with this event.The device was returned to olympus for a device evaluation and found residual liquid or foreign material came out of the channel tube.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for a device evaluation and the customer¿s allegation was confirmed.In addition to the reported in b5, the device evaluation found the following: the connecting tube had a dent, the adhesive on the bending section cover rubber 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 forceps could not be inserted smoothly, the image guide bundle had significant breakages, due to damage on the image guide bundle the image had a stain, the control unit had a scratch, the grip had a scratch, and the camera section had a scratch.The customer did clean, disinfect, sterilized the device before returning to olympus.The customer aspirated water through the instrument/suction channel, wiped/brushed the instrument channel outlet with clean lint-free cloths, brushes, or sponges, brushed the instrument channel, instrument channel port, and suction cylinder with a delay in the pre-cleaning and no abnormalities observed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
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 definitive root cause of the foreign material could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: inspection methods associated with reprocessing are described in ¿operation manual maf-tm/gm chapter 3 preparation and inspection¿, and prevention methods are described in ¿reprocessing manual maf-tm/gm chapter 8 cleaning, disinfection, and sterilization¿.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: 17786378
• Report Number: 9610595-2023-13735
• Device Sequence Number: 20696406
• Product Code: EOQ
• UDI-Device Identifier: 04953170407147
• UDI-Public: 04953170407147
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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-TM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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