n.a. 8575KDRecalls & reported problems
Karl Storz GmbH & Co. KG · Support Rod, 34 cm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551210932), received between Aug 27, 2025 and Aug 18, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Key or Button Unresponsive/not Working2
- Material Fragmentation2
- Mechanical Jam1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304019 ↗InjuryAug 27, 2025Material Fragmentation; Key or Button Unresponsive/not Working; Material Fragmentation; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THERE IS A DEFECT ADJUSTMENT WHEEL ON A LARYNGOSCOPE HOLDER. THE WHEEL WAS STUCK AND NOT ABLE TO ROTATE THE FULL ANGULATION DURING PROCEDURE. SOME TINY METAL FRAGMENTS WERE FOUND ON THE GEAR AFTER PROCEDURE. ACORDING TO THE CUSTOMER NO FRAGMENTS FELL IN PATIENT. THE SURGERY WAS PROLONGED FOR 30 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906100 ↗MalfunctionAug 27, 2025Material Fragmentation; Mechanical Jam; Key or Button Unresponsive/not Working; Material Fragmentation; Mechanical Jam; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THERE IS A DEFECT ADJUSTMENT WHEEL ON A LARYNGOSCOPE HOLDER. THE WHEEL WAS STUCK AND NOT ABLE TO ROTATE THE FULL ANGULATION DURING PROCEDURE. SOME TINY METAL FRAGMENTS WERE FOUND ON THE GEAR AFTER PROCEDURE. ACORDING TO THE CUSTOMER NO FRAGMENTS FELL IN PATIENT. THE SURGERY WAS PROLONGED FOR 30 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905310 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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