IntuBrite 2016.CRecalls & reported problems
Salter Labs · Pediatric SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607411964428), received between Oct 20, 2023 and Mar 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem2
- Material Integrity Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Respiratory Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Mechanical Problem; Mechanical Problem
ALTHOUGH NO HARM OR INJURY WAS REPORTED FOR THIS INCIDENT, THE LARYNGOSCOPE LIGHT NOT WORKING DURING PATIENT INTUBATION WOULD CAUSE A DELAY IN SECURING THE PATIENT'S AIRWAY AND WOULD POSE A RISK OF SERIOUS HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692071 ↗MalfunctionMar 20, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
LIGHT ON LARYNGOSCOPE HANDLE/BLADE WENT OUT AFTER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946340 ↗MalfunctionOct 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
LIGHTS NOT COMING ON, MULTIPLE LARYNGOSCOPE HANDLES. "WE WERE TRYING TO INTUBATE A BABY AND THE LARYNGOSCOPE HANDLE LIGHT WOULDN'T COME ON. WE THEN GRABBED A SECOND HANDLE AND THE LIGHT ON THAT ONE WOULDN'T COME ON EITHER THIS RESULTED IN A DELAY OF CARE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18016401 ↗MalfunctionOct 20, 2023Material Integrity Problem; Material Integrity Problem
WOULD NOT LIGHT UP. DELAY IN INTUBATION. THE 1ST AND 2ND DEVICE DID NOT LIGHT UP, THE 3RD DEVICE DID WORK.
Patient problems: Unspecified Respiratory Problem
MAUDE report 17978022 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.