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
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to a pinhole on a-rubber, water tightness is lost, due to a damage on camera section, water tightness is lost, a-rubber has cut, connecting tube has a wrinkle and scratch, due to wear of angle wire, bending angle in up direction does not meet specifications, battery/card cover is sticky, and image guide bundle has a stain.Due to the nature of this reportable event, the customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The device was not cleaned, sanitized or disinfected prior to being sent for repair.Facility was not aware, noted ¿no¿ as to when the foreign matter adhered on the device.¿ did not provide additional information.The customer confirmed that the facility does not delay the start of precleaning of the equipment after use.Customer noted normal, no abnormalities on the accessories used for reprocessing.The customer noted ¿unknown¿ that the facility wipes or brushes the air and water nozzle with a gauze, brush, or sponge.Facility did not flush the air/water nozzle with water and air.Facility did not flush air/water nozzle with detergent solution.The investigation is pending.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 customer reported to olympus that the airway mobilescope had a bending section pinhole.During inspection and evaluation, a foreign object came out of the forceps channel.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and 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, it is likely that the foreign material might have remained since the reprocessing has not correctly been implemented in line with the instructions for use (ifu).A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "inspection of the endoscope.1.Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities.2.Confirm that the instrument channel port does not rotate or turn by attempting to rotate or turn the instrument channel port in a counterclockwise direction as shown in figure 3.21.If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to olympus for repair.Inspection of the instrument channel (for maf-tm).1.Insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.2.Confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve." olympus will continue to monitor the field performance of 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: 16770794
• Report Number: 9610595-2023-06348
• Device Sequence Number: 14237918
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 03/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2012
• 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