C-MAC 8403XSIRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551408315), received between Dec 17, 2018 and Sep 18, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830696 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616690 ↗
• 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 50008561 ↗
• MalfunctionJun 16, 2026No Display/Image

  IT WAS REPORTED WHEN PLUGGING IN THE UNIT TO ANY CONNECTION CABLE, THERE IS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522836 ↗
• MalfunctionFeb 4, 2026No Display/Image

  IT WAS REPORTED THAT "WE RECEIVED IT AND IT DIDN'T WORK FROM THE START. THE LIGHT IS WORKING, BUT THERE IS NO PICTURE. WE ALSO TRIED IT ON OTHER DEVICES - IT DOESN'T WORK". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264846 ↗
• MalfunctionJan 27, 2026No Display/Image

  IT WAS REPORTED THAT "UNIT HAVING NO IMAGE WHEN CONNECT TO C MAC MONITOR.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190245 ↗
• MalfunctionDec 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DEVICE GLITCHES OUT AND DOES NOT POWER ON CONSTANTLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694535 ↗
• MalfunctionAug 27, 2025No Display/Image; Device Handling Problem; No Display/Image; Device Handling Problem

  IT WAS REPORTED THE DEVICE DOESN'T TURN ON AND CONSEQUENTLY NO IMAGE IS SHOWN DURING INSTALLATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904355 ↗
• MalfunctionJun 10, 2025Device Reprocessing Problem; Optical Problem; Device Reprocessing Problem; Optical Problem

  IT WAS REPORTED THAT THE LIGHT IS DEFECTIVE, NO LIGHT ILLUMINATION. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176221 ↗
• MalfunctionMay 24, 2025Device Reprocessing Problem; Display or Visual Feedback Problem; Poor Quality Image; Device Reprocessing Problem; Display or Visual Feedback Problem; Poor Quality Image

  IT WAS REPORTED THAT "THE WIRE IS DEPRESSED. THERE IS NO IMAGE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082433 ↗
• MalfunctionDec 17, 2018Difficult to Insert; Detachment of Device or Device Component; Mechanical Jam; Separation Problem

  PHYSICIAN WAS SETTING UP A STORZ 8403SXI C-MAC S VIDEO LARYNGOSCOPE HANDLE IN PREPARATION FOR USE. WHILE INSERTING THE SCOPE INTO THE DISPOSABLE LARYNGOSCOPE BLADE HE INADVERTENTLY INSERTED THE HANDLE APPROXIMATELY 180 DEGREES OUT OF POSITION CAUSING THE SPRING-LOADED RETAINER ON THE END CAP OF THE C-MAC HANDLE TO BECOME JAMMED IN THE TOP OF THE DISPOSABLE BLADE. ON ATTEMPTING TO REMOVE THE HANDLE FROM THE BLADE, THE PRESS-FIT END CAP OF THE C-MAC HANDLE BECAME COMPLETELY SEPARATED FROM THE BODY OF THE HANDLE, AND THE RIBBON CONNECTOR DETACHED FROM THE CIRCUIT BOARD IN THE HANDLE BODY. THE C-MAC HANDLE WAS RENDERED UNUSABLE. MANUFACTURER RESPONSE FOR VIDEO LARYNGOSCOPE, C-MAC S (PER SITE REPORTER). LOCAL CLINICAL REP VIEWED THE EQUIPMENT IN QUESTION, STATED HE WAS NOT AWARE OF THIS FAILURE HAPPENING ELSEWHERE, AND AGREED THAT IT SHOULD BE REPLACED UNDER WARRANTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168831 ↗