BritePro Omni Single-Use Laryngoscope Mini Handle With Miller 0 040-06-0401URecalls & reported problems
Flexicare Medical Limited · Class 1
Data updated Oct 18, 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 05055788773306), received between Dec 6, 2024 and Dec 9, 2024 — classified as 3 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
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.
MalfunctionDec 9, 2024
USING 0 BLADE ON 3KG BABY. LESS CURVE TO THE BLADE NOTED. THE BLADE IS DISPLACED TO THE RIGHT. NEARLY IMPOSSIBLE TO SLIDE THE ENDOTRACHEAL TUBE ALONGSIDE THE BLADE TO MAINTAIN VISUALIZATION OF THE VOCAL CORDS. TUBE WANTS TO SLIDE INTO THE BLADE COMPLETELY OBSTRUCTING VIEW OF THE CORDS. MANUFACTURER RESPONSE FOR LARYNGOSCOPE, RIGID, BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 0 (PER SITE REPORTER). RECOMMENDED WE PROVIDE MORE EDUCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878028 ↗MalfunctionDec 6, 2024
ATTEMPTING TO INTUBATE NEONATAL INTENSIVE CARE UNIT (NICU) INFANT. WHEN VISUALIZING THE TRACHEA, THE BLADE IS NOTED TO DEVIATE TO THE RIGHT. HAD TROUBLE STABILIZING THE EPIGLOTTIS AND BLADE SLIPPED. FLEXICARE BLADE IS SLICK VERSUS PREVIOUS BLADES USED THAT WERE MATTE. WHEN LOOKING DOWN FROM ABOVE, WITH BLADE OPEN ON HANDLE, THE BLADE IS ON THE SIDE. WHEN LIFTING UP, THE PRESSURE IS TO THE SIDE, DISTORTING THE VIEW. MANUFACTURER RESPONSE FOR LARYNGOSCOPE, RIGID, BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 0 (PER SITE REPORTER) RECOMMENDED WE PROVIDE MORE EDUCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863237 ↗MalfunctionDec 6, 2024
THE THICKNESS OF THE BLADE MADE INSERTING THE ENDOTRACHEAL TUBE (ETT) MUCH MORE DIFFICULT, SO THAT IT TOOK MULTIPLE ATTEMPTS. THERE WAS BLOOD IN THE MOUTH AND THE ONLY WAY I COULD GET THE ETT PAST THE BLADE WAS TO INSERT IT DOWN THE CENTER OF THE TRACK IN THE BLADE, WHICH MADE THE INTUBATION BLIND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863220 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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