NA 8404EXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551441992), received between May 2, 2025 and Sep 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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 10 most recent of 10 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 50924459 ↗
• MalfunctionSep 28, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923273 ↗
• MalfunctionSep 8, 2026Loss of or Failure to Bond; Poor Quality Image; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675841 ↗
• MalfunctionAug 26, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50463992 ↗
• MalfunctionMay 18, 2026No Display/Image

  IT WAS REPORTED THERE WAS NO VIDEO IMAGE DISPLAYED ON THE MONITOR WHEN THE BLADE IS CONNECTED. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200736 ↗
• MalfunctionJan 9, 2026Device Reprocessing Problem; Energy Output Problem

  IT WAS REPORTED THE LIGHT IS NOT WORKING. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020681 ↗
• MalfunctionNov 3, 2025Device Reprocessing Problem; Image Display Error/Artifact; Poor Quality Image; Device Reprocessing Problem; Image Display Error/Artifact; Poor Quality Image

  IT WAS REPORTED THERE WAS AN ISSUE WITH VISUALIZATION; BLACK SCREEN, LINES OVER THE SCREEN AND BLURRINESS. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451761 ↗
• MalfunctionAug 20, 2025Device Reprocessing Problem; Optical Problem; Device Reprocessing Problem; Optical Problem

  IT WAS REPORTED THE LIGHT IS VERY LOW AND IMAGE IS DARK. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22849118 ↗
• MalfunctionJun 11, 2025Device Reprocessing Problem; Optical Problem; Device Reprocessing Problem; Optical Problem

  INITIALLY IT WAS REPORTED "ABSENCE OF LIGHT DURING INTUBATION - BLACK IMAGE" AND LATER IT WAS STATED "DEFECTIVE CMAC INTUBATION BLADE NO. 1. NO LIGHT WHEN INSPECTING THE BLADE. IMPOSSIBLE TO PERFORM AN INTUBATION UNDER THESE CONDITIONS". IT WAS FURTHERMORE INDICATED THAT THE ISSUE WAS DETECTED DURING A CHECK, A BACKUP LARYNGOSCOPE WAS AVAILABLE FOR USE, THE INTUBATION SITUATION WAS NO EMERGENCY INTUBATION AND THERE WERE NO ADVERSE CONSEQUENCES FOR ANY PATIENT, USER OR THIRD PARTY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190409 ↗
• MalfunctionMay 2, 2025Device Reprocessing Problem; Electrical /Electronic Property Problem; Optical Problem; Device Reprocessing Problem; Electrical /Electronic Property Problem; Optical Problem

  IT WAS REPORTED THAT THE PRODUCT FAILED. INSUFFICIENT LIGHT. NO HARM TO PATIENT, USER OR THIRD AND NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955683 ↗