GlideScope® Spectrum™ DirectView™ MAC S4Recalls & reported problems
Verathon Medical (Canada) ULC · GlideScope® Spectrum™ DirectView™ MAC S4 · Class 1
All models of GlideScope (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00879123006257), received between Jan 27, 2026 and Jun 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem3
- Erratic or Intermittent Display2
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem
A CUSTOMER REPORTED THE SCREEN ON THEIR GLIDESCOPE AVL SYSTEM WENT BLACK WHEN THE GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4 LARYNGOSCOPE WAS INSERTED INTO THE PATIENT'S MOUTH AND RETURNED TO NORMAL WHEN REMOVED. THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT REPORTED BEING UNABLE TO REPLICATE THE ISSUE USING A DIFFERENT GLIDESCOPE BLADE. NO DELAY IN PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT WAS REPORTED. THE INCIDENT DATE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522209 ↗MalfunctionMay 20, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem
A CUSTOMER REPORTED THE SCREEN ON THEIR GLIDESCOPE AVL SYSTEM WENT BLACK WHEN THE GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4 LARYNGOSCOPE WAS INSERTED INTO THE PATIENT'S MOUTH AND RETURNED TO NORMAL WHEN REMOVED. THE ISSUE REPORTEDLY OCCURRED THREE TIMES DURING THE PATIENT PROCEDURE. THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT REPORTED BEING UNABLE TO REPLICATE THE ISSUE USING A DIFFERENT GLIDESCOPE BLADE. NO DELAY IN PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231604 ↗MalfunctionJan 27, 2026No Display/Image; Display or Visual Feedback Problem
A CUSTOMER REPORTED UPON LARYNGOSCOPY, IT WAS NOTED THAT THE CAMERA ON THE GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4 LARYNGOSCOPE WAS WORKING; HOWEVER, THERE WAS NO LIGHT SOURCE RESULTING IN A BLACK/DARK SCREEN WITH NO VISIBLE ANATOMY WHEN THE BLADE WAS INSERTED INTO THE PATIENT. THE INTUBATION ATTEMPT WAS TEMPORARILY ABANDONED AS USERS OBTAINED A SECONDARY GLIDESCOPE UNIT WHILE BAG-MASK-VENTILATING THE PATIENT. THE INTUBATION WAS SUCCESSFULLY COMPLETED USING A REUSABLE GLIDESCOPE BLADE. NO DELAY IN PROCEDURE OR HARM TO THE PATIENT WAS REPORTED. THE DATE OF EVENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192369 ↗
Other Laryngoscope, Rigid devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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