C-MAC 8403ZXRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC® Monitor for CMOS Endoscopes · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551337912), received between Jun 16, 2025 and Jul 27, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 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
- Display or Visual Feedback Problem2
- Output Problem2
- Connection Problem1
- Failure to Charge1
- Failure to Conduct1
- Loose or Intermittent Connection1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Mechanical Problem; Output Problem
The following was reported: During a procedure yesterday, the device switched off. There was an intermittent electrical/contact failure while the video system was being used in an emergency situation. The procedure was completed successfully but medical, surgical, or diagnostic intervention was required. No adverse consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008562 ↗MalfunctionApr 6, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT VIDEO LARYNGOSCOPE TURNED OFF AGAIN DURING INTUBATION. INOTHER WORDS, THE SCREEN WENT COMPLETELY OFF. TURNED BACK ON BY ITSELF. THIS IS THESAME LARYNGOSCOPE THAT HAD PREVIOUSLY HAD THIS SAME PROBLEM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792756 ↗MalfunctionJan 8, 2026Optical Problem
IT WAS REPORTED THAT DURING INTUBATION, THE SCREEN TURNS BLACK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24007842 ↗MalfunctionNov 7, 2025Display or Visual Feedback Problem; Loose or Intermittent Connection; Display or Visual Feedback Problem; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING BRONCHOSCOPY, SCREEN FAILURE, INTERRUPTION AND BLACK AND WHITE IMAGES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498697 ↗MalfunctionAug 19, 2025Failure to Charge; Connection Problem; Failure to Charge; Connection Problem
IT WAS REPORTED THAT THE C-MAC MONITOR CANNOT BE CHARGED AT ALL AND IS UNABLE TO POWER ON. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22845361 ↗MalfunctionAug 14, 2025Failure to Conduct; Output Problem; Failure to Conduct; Output Problem
IT WAS REPORTED "MONITOR SWITCHES OFF AFTER A VERY SHORT TIME". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809841 ↗MalfunctionJun 16, 2025No Display/Image; Material Deformation; No Display/Image; Material Deformation
IT WAS REPORTED BLACKED OUT MID INTUBATION. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 15 MINUTES AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212655 ↗
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.