NA 8403XDRecalls & reported problems
Karl Storz GmbH & Co. KG · C-MAC Pocket Monitor · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551396032), received between May 2, 2025 and Dec 11, 2025 — classified as 2 deaths, 7 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (3 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
- Optical Problem3
- Adverse Event Without Identified Device or Use Problem2
- No Display/Image2
- Output Problem2
- Connection Problem1
- Device Reprocessing Problem1
- Display or Visual Feedback Problem1
- Electrical /Electronic Property Problem1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Loose or Intermittent Connection
THE FOLLOWING WAS REPORTED: NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23779867 ↗MalfunctionOct 24, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THERE WAS "HARDWARE: WHEN TURNING THE MONITOR LEFT/RIGHT, IT OCCASIONALLY SWITCHES OFF, LOOSE CONNECTION, THE DATA CANNOT BE READ ON THE PC BECAUSE IT IS NOT RECOGNIZED BY EXPLORER.". NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381730 ↗MalfunctionAug 22, 2025Output Problem; Output Problem
IT WAS REPORTED THAT IMAGE FREEZES WHEN THE MONITOR IS ROTATED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22876890 ↗MalfunctionAug 14, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem
IT WAS REPORTED THAT THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22801811 ↗MalfunctionAug 4, 2025Connection Problem; Optical Problem; Connection Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22701306 ↗DeathJul 30, 2025Optical Problem; Optical Problem
ACCORDING TO THE INFORMATION RECEIVED, IMAGE DROPOUTS. IT WAS CONFIRMED BY DOCTOR THAT THE PATIENT HAD ALREADY DIED BY THE TIME PARAMEDIC TEAM ARRIVED, BUT ATTEMPTS WERE STILL MADE TO SECURE THE AIRWAY. DATE OF DEATH IS UNKNOWN. DOCTOR/PARAMEDIC CONFIRMED THAT THE DEVICE FAILURE NEITHER CAUSED NOR CONTRIBUTED TO THE PATIENT'S DEATH. APPROPRIATE REPLACEMENT EQUIPMENT WAS AVAILABLE AT THE TIME OF USE.
Patient problems: Insufficient Information
MAUDE report 22670796 ↗DeathJul 30, 2025Optical Problem; Optical Problem
ACCORDING TO THE INFORMATION RECEIVED, IMAGE DROPOUTS. IT WAS CONFIRMED BY DOCTOR THAT THE PATIENT HAD ALREADY DIED BY THE TIME PARAMEDIC TEAM ARRIVED, BUT ATTEMPTS WERE STILL MADE TO SECURE THE AIRWAY. DATE OF DEATH IS UNKNOWN. DOCTOR/PARAMEDIC CONFIRMED THAT THE DEVICE FAILURE NEITHER CAUSED NOR CONTRIBUTED TO THE PATIENT'S DEATH. APPROPRIATE REPLACEMENT EQUIPMENT WAS AVAILABLE AT THE TIME OF USE.
Patient problems: Insufficient Information
MAUDE report 22670717 ↗MalfunctionJul 11, 2025No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "OCCASIONALLY NO IMAGE, PHOTO/VIDEO RESOLUTION DOES NOT WORK." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22487160 ↗MalfunctionMay 2, 2025No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT "WHEN MOVING THE MONITOR, THE PICTURE CUTS OUT, LOOSE CONTACT AT THE CONNECTION SOCKET". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21955671 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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