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

Model Number	BFLEX¿ 3.8
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Glidescope broke during intubation.The tip of the glidescope was lodged in the et tube.

• Brand Name: GLIDESCOPE®
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON INC.; 20001 n creek pkwy; bothell WA 98011
• MDR Report Key: 16416699
• Report Number: 16416699
• Device Sequence Number: 5742756
• Product Code: EOQ
• UDI-Device Identifier: 00879123006394
• UDI-Public: (01)00879123006394
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/27/2023
• Report Date (Section F): 01/27/2023

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¿ 3.8
• Device Catalogue Number: 0570-0380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• 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: 01/27/2023