n.a. 8404BXCRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC Video Laryngoscope MAC #4 · Class 1
Quick summary
This Karl Storz C-MAC is a video laryngoscope. Many of the 136 reports describe no image or a poor image on the screen, dim or flickering lights, and some mention problems with cleaning and preparing the device. There are no deaths and 2 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 04048551441923), received between Oct 25, 2024 and Sep 28, 2026 — classified as 2 injuries, 139 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (62 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
- Optical Problem62
- Device Reprocessing Problem55
- Output below Specifications26
- Poor Quality Image25
- No Display/Image16
- Display or Visual Feedback Problem13
- Electrical /Electronic Property Problem6
- Energy Output Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- Insufficient Information13
- Hypoxia1
Recent adverse event reports
The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924223 ↗MalfunctionSep 25, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904473 ↗MalfunctionSep 24, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891926 ↗MalfunctionSep 23, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873607 ↗MalfunctionSep 22, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860221 ↗MalfunctionSep 22, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860219 ↗MalfunctionSep 16, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794720 ↗MalfunctionSep 14, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765018 ↗MalfunctionSep 9, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697619 ↗MalfunctionSep 9, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695905 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619730 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619724 ↗MalfunctionAug 31, 2026Output below Specifications
Patient problems: Insufficient Information
MAUDE report 50529348 ↗MalfunctionAug 27, 2026Output below Specifications
The following was reported: 8404BXC reported with lights on when connected to video monitor, but there is no image and the light was also very dull. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487496 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328237 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328235 ↗MalfunctionAug 13, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237565 ↗MalfunctionAug 13, 2026Output below Specifications
The following was reported: Both LEDs dim and flickering. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237267 ↗MalfunctionAug 13, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237257 ↗MalfunctionAug 12, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224737 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond; No Display/Image; Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162127 ↗MalfunctionAug 6, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161137 ↗MalfunctionAug 5, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150330 ↗MalfunctionAug 4, 2026Output below Specifications
It was reported that there is insufficient lighting. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133814 ↗MalfunctionJul 29, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070171 ↗
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 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
- GlideScope® GlideScope® Core™ 15 FHDVerathon Medical (Canada) ULC · Laryngoscope, Rigid1 recall30 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.