MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC BFLEX¿; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	BFLEX¿ 2 REGULAR 5.0
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After set-up everything seemed to be working fine.When scope was moved into position to place in ett the monitor screen went black.Has been reported & rep picked up.Manufacturer response for bronchoscope (flexible or rigid), bflex¿ (per site reporter).Rep picked up product.

• Brand Name: BFLEX¿
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC; 20001 n creek pkwy; bothell WA 98011
• MDR Report Key: 20619756
• Report Number: 20619756
• Device Sequence Number: 8820797
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024
• Report Date (Section F): 08/26/2024

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: Other
• Device Model Number: BFLEX¿ 2 REGULAR 5.0
• Device Catalogue Number: 0570-0423
• Device Lot Number: KS241802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/26/2024