MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BORNCHON SCOPE EB-580T; BRONCHON SCOPE

Model Number EB-580T

Device Problems Microbial Contamination of Device (2303); Scratched Material (3020)

Patient Problem Bacterial Infection (1735)

Event Date 02/06/2024

Event Type  Injury  

Event Description

On (b)(6) fujifilm healthcare americas corporation was informed of an event involving eb-580t.It was reported that there is a concern for potential defect inside the scope that could be a source for harboring bacteria.3 patients test positive with a rare bacteria and are trying to identify a source.

Manufacturer Narrative

(b)(4).

• Brand Name: FUJIFILM BORNCHON SCOPE EB-580T
• Type of Device: BRONCHON SCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyandai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18860878
• MDR Text Key: 337185144
• Report Number: 1000513161-2024-00016
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024,03/07/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: EB-580T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other