IntuBrite 1020.C2016.CRecalls & reported problems
Salter Labs · MAC 0 SINGLE USE DISPOSABLE LARYNGOSCOPE BLADE and HANDLE SYSTEM · Class 1
- 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 00607411966408), received between Jun 9, 2022 and Sep 9, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical 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.
Most reported problems
Device problems
- Mechanical Problem2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2022Mechanical Problem; Mechanical Problem
BLADE DID NOT PROPERLY LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15394999 ↗MalfunctionSep 8, 2022Mechanical Problem; Mechanical Problem
BLADE DID NOT PROPERLY LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15381681 ↗MalfunctionJun 9, 2022Defective Device
LIGHT IS FLICKERING. POSSIBLE DELAYED INTUBATION.
Patient problems: Insufficient Information
MAUDE report 14645411 ↗
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.