n.a. 8404HXRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC Video Laryngoscope D-BLADE · Class 1
Quick summary
This Karl Storz C-MAC video laryngoscope is a rigid laryngoscope. The 238 reports mostly describe dim, flickering or poor-quality images, optical problems, and problems with cleaning and reprocessing the device. The reports include 3 injuries and no deaths, and some of the recent reports note no negative impact on health. 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
- 242
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 04048551441862), received between Oct 25, 2024 and Sep 28, 2026 — classified as 3 injuries, 239 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (149 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 Problem149
- Device Reprocessing Problem121
- Poor Quality Image69
- Output below Specifications26
- No Display/Image22
- Electrical /Electronic Property Problem14
- Display or Visual Feedback Problem11
- Output Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions226
- Insufficient Information21
- Unspecified Respiratory Problem3
Recent adverse event reports
The 25 most recent of 242 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 50925964 ↗MalfunctionSep 28, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917944 ↗MalfunctionSep 24, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891925 ↗MalfunctionSep 22, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860223 ↗MalfunctionSep 16, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793627 ↗MalfunctionSep 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717002 ↗MalfunctionSep 9, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695348 ↗MalfunctionSep 8, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675843 ↗MalfunctionSep 4, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619728 ↗MalfunctionAug 27, 2026Output below Specifications
The following was reported: "8404HX reported with dim light, and poor image quality." No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481859 ↗MalfunctionAug 21, 2026Output below Specifications
It was reported that the light output is dim and flickering. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379045 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333822 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333821 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328251 ↗MalfunctionAug 19, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328247 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241325 ↗MalfunctionAug 3, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116993 ↗MalfunctionJul 29, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070322 ↗MalfunctionJul 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063896 ↗MalfunctionJul 27, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50039049 ↗MalfunctionJul 17, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856642 ↗MalfunctionJul 13, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798235 ↗MalfunctionJul 8, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749885 ↗MalfunctionJul 2, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT BAD LIGHT OUTPUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25695718 ↗MalfunctionJun 18, 2026No Display/Image
IT WAS REPORTED THERE WAS DIM TO NO IMAGE. NO PATIENT OR PROCEDURE INVOLVEMENT NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25548247 ↗
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
- 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
- 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.