C-MAC 8403XRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551389225), received between Aug 7, 2023 and Aug 12, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (4 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 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. Cross reference MDR: 9610617-2026-01714, 9610617-2026-01715, 9610617-2026-01860, 9610617-2026-01861.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225679 ↗
• InjuryAug 12, 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. Cross reference MDR: 9610617-2026-01714; 9610617-2026-01715; 9610617-2026-01860; 9610617-2026-01861.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225677 ↗
• MalfunctionJul 30, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091719 ↗
• MalfunctionApr 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT VIDEO LARYNGOSCOPE TURNED OFF AGAIN DURING INTUBATION. IN OTHER WORDS, THE SCREEN WENT COMPLETELY OFF. TURNED BACK ON BY ITSELF. THIS IS THE SAME 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 24792757 ↗
• MalfunctionNov 5, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THE CABLE CAUSED GLITCHING WHEN PLUGGED INTO BLADES. THE INTUBATION WAS COMPLETED SUCCESSFULLY WITH A 20 MINS DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476605 ↗
• MalfunctionNov 3, 2025Optical Problem; No Apparent Adverse Event; Optical Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT IMAGE GETS DARK WHEN BLADE IS CONTACT WITH METAL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445483 ↗
• MalfunctionSep 19, 2025Intermittent Continuity; Intermittent Continuity; Loose or Intermittent Connection; No Apparent Adverse Event

  IT WAS REPORTED THERE WAS AN INTERMITTENT CONNECTION ISSUE WITH THE DEVICE. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096436 ↗
• MalfunctionSep 19, 2025Intermittent Continuity; Connection Problem; Intermittent Continuity; Connection Problem

  IT WAS REPORTED THERE WAS AN INTERMITTENT CONNECTION ISSUE WITH THE DEVICE. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096398 ↗
• MalfunctionSep 19, 2025Failure to Conduct; Intermittent Continuity; Device Handling Problem; Failure to Conduct; Intermittent Continuity; Device Handling Problem

  IT WAS REPORTED THERE WAS AN INTERMITTENT CONNECTION ISSUE WITH THE DEVICE. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096392 ↗
• MalfunctionAug 25, 2025Device Handling Problem; Intermittent Loss of Power; Device Handling Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE C-MAC CONNECTING CABLE HAS A LOOSE CONTACT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891780 ↗
• MalfunctionJul 25, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, CMAC FAILED MID INTUBATION. SCREEN FLICKED AND LIGHT WENT OUT ON LARYNGOSCOPE HANDLE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613030 ↗
• MalfunctionMay 28, 2025Output Problem; Device Handling Problem; Output Problem; Device Handling Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE CONNECTION BETWEEN CAMERA AND SCREEN. IT FREEZES AND THEN BLACKS OUT. IT HAPPENED MID INTUBATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099031 ↗
• MalfunctionMar 24, 2025Loose or Intermittent Connection; Device Handling Problem; Loose or Intermittent Connection; Device Handling Problem

  IT WAS REPORTED THAT DURING INSTALLATION OF THE DEVICE, THE CONNECTION WOULD CUT ON AND OFF WHEN THE CABLE BASE IS MOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684449 ↗
• InjuryAug 7, 2023Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 8403ZX - C-MAC MONITOR FOR CMOS ENDOSCOPES. LOOSE CONTACT DURING INTUBATION. IT WAS REPORTED THAT "DURING A LARYNGOSCOPY, THE SCREEN GOES BLACK AND THE LIGHT ALSO GOES OUT, SO THAT DIRECT LARYNGOSCOPY IS ALSO NOT POSSIBLE. AFTER WIGGLING BOTH CONTACTS (CABLE-HANDLE AND CABLE-SCREEN), LIGHT AND IMAGE GO AGAIN AFTER A FEW SECONDS. INTUBATION IS SIGNIFICANTLY DELAYED AND NO STATEMENT ABOUT POSSIBLE ASPIRATION/REGURGITATION IS POSSIBLE FOR A SHORT TIME." THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470390 ↗