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

Model Number	MAF-TM2
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).Three attempts were performed to obtain additional information, but no response was received from the customer.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00224.
Event or Problem Description
It was reported the endoscopy support specialist (ess) was contacted by the customer regarding a patient testing positive for carbapenem-resistant enterobacterales (cre).The bronchovideoscope and airway mobilescope were both used on the patient and the customer was inquiring whether the reprocessor and acecide high level disinfectant were suitable to properly clean the endoscopes.The customer reported they were not sure if the patient was infected by the use of the videoscopes or if the patient already had the infection.A culture test was performed on the two endoscopes and the results came back negative.Additional information regarding the event was requested, but not provided at the time of this report.
Event or Problem Description
Additional information received that the patient's infection was verified by blood cultures.The reprocessor was not cultured.Only the scopes that were used on the patient were cultured, which came back negative for carbapenem-resistant enterobacterales (cre).At the time of this report, the patient was discharged from the hospital and there were no other patients that developed cre after using the scope.The facility was not sure if the patient came into the hospital with cre or is he developed it during the hospital stay.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information regarding the reported event.New information added to the following fields: a3, b5, and h10.This report has been submitted by the importer under this mdr report number 2429304 - 2024 - 00224.
Event or Problem Description
This report is being supplemented to provide additional information provided by the customer.It was reported, each scope was used on the patient on two separate dates.During the patient's hospitalization, the bronchovideoscope was used on (b)(6) 2024 and the airway mobilescope was used on (b)(6) 2024.The customer confirmed the same scopes were used on different patients, but there were no confirmed subsequent infections at this time.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information inadvertently left out as reflected in b5.This report has been submitted by the importer under this supplemental mdr report number (b)(4).
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.Despite good faith attempts, the user culture results and cleaning disinfection and sterilization (cds) processes were not shared and/or provided.Based on the results of the investigation, the subject device was not returned.Therefore, olympus was not able to judge the relation between the subject device and the event from the following investigation results.The root cause of the reported event could not be identified.The event can be prevented, by following the instructions for use, which state: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them¿.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: 19105718
• Report Number: 9610595-2024-07868
• Device Sequence Number: 12598553
• Product Code: EOQ
• UDI-Device Identifier: 04953170407147
• UDI-Public: 04953170407147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAF-TM2
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/23/2024; 07/31/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/24/2024; 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male