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

Model Number	MAF-TM
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
Additional Manufacturer Narrative
E1 establishment name and address: (b)(6).The device was returned and evaluated, and the customer¿s allegation of a compromised image was confirmed.Additional issues were identified during the device evaluation: the image had a stain due to damage to the image guide bundle, the connecting tube had a wrinkle, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, and the connecting tube had a dent.The foreign material found has been attributed to insufficient cleaning.The customer was unable to provide any cleaning, disinfecting, or sterilizing processes.It was unknown if the device was cleaned, disinfected, and sterilized before it was sent in for repair.It is unknown if the customer has any idea when the foreign material adhered to the endoscope or what the material was.It is unknown if there was a delay in the start of the precleaning or abnormalities in the accessories used for reprocessing.It is also unknown if the customer flushed the air or water nozzle with water and air and wiped or brushed the air or water nozzle with clean, lint-free cloths, brushes, or sponges.Lastly, it is unknown if the customer flushed the air/water nozzle channel with the detergent solution or presoaked the endoscope in the detergent solution.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The olympus representative reported (on behalf of the customer) that the airway mobilescope had a compromised image.There were no reports of patient harm.During evaluation of the returned device, it was found that a foreign objects came out of forceps channel and therefore is considered a medical device report (mdr).This 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 foreign material could not be identified nor the root cause of it.The event can be detected/prevented in accordance with below ifu.Inspection method is described in the operation manual maf-tm/gm chapter 3 preparation and inspection.Prevention method is described in the reprocessing manual in maf-tm/gm chapter 8 cleaning, disinfection, and sterilization procedures.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: 17627766
• Report Number: 9610595-2023-12262
• Device Sequence Number: 12283063
• 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): 10/13/2023

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: 07/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2011
• 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