MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC. GLIDESCOPE SPECTRUM; LARYNGOSCOPE, RIGID

Model Number LOPRO S4

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2023

Event Type  malfunction  

Event Description

Guidescope spectrum screen went blank during intubation of patient.New spectrum was obtained and connection appeared to work.

• Brand Name: GLIDESCOPE SPECTRUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC.
• MDR Report Key: 16683537
• MDR Text Key: 312863156
• Report Number: MW5116316
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: LOPRO S4
• Device Catalogue Number: 0574-0195
• Device Lot Number: GU68554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female