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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All LARYNGOSCOPE, RIGID devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.