MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC GLIDESCOPE LOPRO S4; LARYNGOSCOPE, RIGID

Model Number GLIDESCOPE LOPRO S4

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  Injury  

Event Description

During emergency intubation, glidescope lo pro s4 failed to light up after several attempts.A new scope was retrieved and used successfully.Fda safety report id # (b)(4).

• Brand Name: GLIDESCOPE LOPRO S4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC
• MDR Report Key: 12413416
• MDR Text Key: 270307083
• Report Number: MW5103671
• Device Sequence Number: 1
• Product Code: CCW
• 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: 08/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLIDESCOPE LOPRO S4
• Device Catalogue Number: GU 77807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR