MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC. GLIDESCOPE®; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	BFLEX¿ 5.8
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of a glidescope bflex 5.8 single-use bronchoscope broch off during a bronchoscopy done at bedside by intensivist in intensive care unit (icu).Patient on extracorporeal membrane oxygenation (ecmo).

• Brand Name: GLIDESCOPE®
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC.; 20001 n creek pkwy; bothell WA 98011
• MDR Report Key: 17548482
• Report Number: 17548482
• Device Sequence Number: 6854737
• Product Code: EOQ
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023
• Report Date (Section F): 07/27/2023

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 Model Number: BFLEX¿ 5.8
• Device Catalogue Number: 0570-0381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White
• Date Report Sent to FDA: 07/27/2023