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
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.This report is related to the following linked patient identifier: (b)(6).
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.
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 enterobacterial (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.

• 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
• MDR Report Key: 19105622
• Report Number: 2429304-2024-00224
• Device Sequence Number: 12715955
• Product Code: EOQ
• UDI-Device Identifier: 04953170407147
• UDI-Public: 04953170407147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024
• Report Date (Section F): 03/22/2024

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?: Yes
• Distributor Facility Aware Date: 04/23/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male