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

Model Number	MAF-GM2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus endoscopy support specialist (ess) became aware during an in-service appointment at the user facility, that the customer did not leak test their scopes, did not do the initial soak of the scope in detergent solution, did not use the correct brushes to brush the channels, used a pistol to flush the channels, and did not use a flushing pump or the suction cleaning adapter tubing for detergent, water or air.Also, the customer did not wipe the scope down and let it soak in detergent solution after suctioning detergent through the channels.There have been no reports of patient injury or infection due to the event.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.The subject device was not returned to olympus for evaluation as there was no report of non-conformity of the device.During the onsite visit, the ess performed in-service on a scope for the sterilization processing department staff, and provided instruction on the cleaning, disinfection, and sterilization (cds) processes per the olympus instructions for use (ifu) for endoscope reprocessing.Recommended staff follow all validated reprocessing steps that are listed in the olympus manual/ifu.Recommended customer leak test the scope after each use.Recommended customer perform the initial soak of the scope in detergent solution.Recommended customer use the correct brushes during reprocessing.Gave customer part numbers of brushes to order.Recommended customer use the suction cleaning adapter to suction the channels with detergent, water and air.Recommended customer wipe the scope down and soak in detergent after suction the channels with detergent.Based on the results of the legal manufacturer¿s investigation, there was a lack of equipment handling and cds training for the user facility staff in accordance with the ifu.However, a definitive root cause could not be determined.The ifu (reprocessing manual) warns against insufficient reprocessing with the following content: 1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.Chapter 4 reprocessing workflow for endoscopes and accessories, 4.2 workflow for manually cleaning and disinfecting endoscopes and accessories describes the conduct of leak tests and manual cleaning processes.5.5 manually cleaning the endoscope and accessories describes the necessary brushes and brushing methods.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15565144
• Report Number: 9610595-2022-02724
• Device Sequence Number: 16890163
• Product Code: EOQ
• UDI-Device Identifier: 04953170407208
• UDI-Public: 04953170407208
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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-GM2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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