n/a 8404AXCRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC Videolaryngoskop MAC #3 · Class 1
Quick summary
This Karl Storz C-MAC video laryngoscope is a camera-equipped tool used to help place breathing tubes. Of its 90 reports, 2 involve injuries and no deaths are recorded. Reports mostly describe dim or flickering lights, poor image quality, and screens showing nothing, and some describe problems during cleaning and sterilization. There were 49 reports in the last 12 months, up from 33 in the year before. 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
- 108
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 04048551441909), received between Jan 18, 2024 and Sep 28, 2026 — classified as 2 injuries, 106 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (34 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 Problem34
- Device Reprocessing Problem33
- Output below Specifications33
- Poor Quality Image26
- Display or Visual Feedback Problem14
- No Display/Image11
- Energy Output Problem4
- Output Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Insufficient Information18
Recent adverse event reports
The 25 most recent of 108 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 50925073 ↗MalfunctionSep 28, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924724 ↗MalfunctionSep 25, 2026Output below Specifications
8404AXC S/N (b)(6) was initially reported with a blurry image. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896989 ↗MalfunctionSep 24, 2026Output below Specifications
The following was reported: 8404AXC reported to have poor dull light. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884962 ↗MalfunctionSep 23, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873997 ↗MalfunctionSep 18, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830697 ↗MalfunctionSep 16, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794729 ↗MalfunctionSep 16, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793626 ↗MalfunctionSep 16, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793625 ↗MalfunctionSep 16, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793624 ↗MalfunctionSep 15, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781815 ↗MalfunctionSep 15, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781814 ↗MalfunctionSep 14, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765020 ↗MalfunctionSep 9, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697621 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50617811 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50617111 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616696 ↗MalfunctionAug 19, 2026No Display/Image
Patient problems: Insufficient Information
MAUDE report 50333820 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333345 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332728 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328231 ↗MalfunctionAug 18, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304606 ↗MalfunctionAug 13, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241326 ↗MalfunctionAug 10, 2026Output below Specifications
The following was reported: "8404AXC has been reported with both LEDs appearing dim and flickering." No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195763 ↗MalfunctionAug 10, 2026Output below Specifications
The following was reported: "8404AXC was reported to exhibit poor light illumination during startup and poor image quality on the screen. Replacement device was used to complete the procedure." No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195550 ↗
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
- 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.