NA 8404GXCRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC Video Laryngoscope MIL #1 · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048551441978), received between May 5, 2025 and Aug 19, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Output below Specifications3
- Device Reprocessing Problem2
- Optical Problem2
- Poor Quality Image2
- Erratic or Intermittent Display1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328243 ↗MalfunctionJul 22, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25905726 ↗MalfunctionJul 20, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875245 ↗MalfunctionMay 29, 2026Erratic or Intermittent Display
IT WAS REPORTED "IMAGE IS FLICKERING". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340513 ↗MalfunctionFeb 13, 2026Device Reprocessing Problem; Optical Problem
IT WAS REPORTED THE DEVICE HAD DIM LIGHT. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332957 ↗MalfunctionFeb 4, 2026Poor Quality Image
IT WAS REPORTED THE SCREEN WAS GLITCHING DURING INTUBATION. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, THERE WAS A 2-3 MINS DELAY. NO PATIENT INJURY REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258268 ↗MalfunctionJul 8, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT DURING A LARYNGOSCOPY THE DISTAL TIP OF BLADE BECAME HOT TO THE TOUCH. PROCEDURE WAS COMPLETED USING A DIFFERENT BLADE. NO SIGNIFICANT DELAY, LESS THAN 15 MINS. NO PATIENT HARM REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435362 ↗MalfunctionMay 5, 2025Device Reprocessing Problem; Poor Quality Image; Optical Problem; Device Reprocessing Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS DIM LIGHT. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21960654 ↗
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.