MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC. VERATHON SCOPE B FLEX2 SLIM 3.8; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Catalog Number	05700432
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
B flex 2 verathon scope completely bent on itself.

• Brand Name: VERATHON SCOPE B FLEX2 SLIM 3.8
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC.
• MDR Report Key: 21786951
• Report Number: MW5168673
• Device Sequence Number: 7909993
• Product Code: EOQ
• UDI-Device Identifier: 00879123008558
• UDI-Public: (01)00879123008558
• 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): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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 Expiration Date: 03/01/2026
• Device Catalogue Number: 05700432
• Device Lot Number: KR240900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2025
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male