BritePro Solo Single-Use Fiber Optic Handle and Blade Mac 4 040-334URecalls & reported problems
Flexicare Medical Limited · BritePro Solo Single-Use Fiber Optic Handle and Blade Mac 4 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055788724124), received between Feb 25, 2021 and Feb 25, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2021Break; Entrapment of Device
CRNA ATTEMPT DL WITH MAC 4 BRITEPRO SOLO DISPOSABLE LARYNGOSCOPE. UPON ATTEMPT BLADE BROKE. BLADE WAS REMOVED BY CRNA. A SECOND LARYNGOSCOPE WAS THEN USED TO INTUBATE THE PATIENT WITHOUT INCIDENT. VISUAL INSPECTION THIS CRNA DURING SECOND INTUBATION DID NOT SHOW OBVIOUS HARM TO PATIENT. AFTER INITIATING SURGERY CLOSER INSPECTION OF THE FAULTY LARYNGOSCOPE BY THIS CRNA SHOWED A MISSING PIECE OF THE BROKEN LARYNGOSCOPE HANDLE. ATTENDING ANESTHESIOLOGIST AND CHIEF ANESTHESIOLOGIST BOTH NOTIFIED, DURING WHICH TIME ANOTHER CRNA LOCATED ALL MISSING PIECES OF THE LARYNGOSCOPE. SURGERY WAS COMPLETED, PATIENT EXTUBATED WITHOUT INCIDENT AND NO COMPLAINTS OR OBVIOUS HARM NOTED IN PACU. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11385154 ↗
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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