NA 091361-01Recalls & reported problems
Karl Storz GmbH & Co. KG · FIVE S 3.5x65, sterile, for single use, · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551422533), received between Sep 8, 2026 and Sep 8, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Poor Quality Image” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Poor Quality Image
It was reported that image interference and distortion occurred during a procedure (two different scoped from same box). Flexing the tip worsened the image quality and made visualization of the area of interest difficult for the veterinarian. The procedure was prolonged by more than 30 minutes but less than 60 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675735 ↗InjurySep 8, 2026Poor Quality Image
It was reported that image interference and distortion occurred during a procedure (two different scoped from same box). Flexing the tip worsened the image quality and made visualization of the area of interest difficult for the veterinarian. The procedure was prolonged by more than 30 minutes but less than 60 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675726 ↗
Other LARYNGOSCOPE, NON-RIGID devices
- n.a. 091361-06Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID10 reports
- n.a. 11301BN1Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID2 reports
- C-MAC 11301BNXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID2 reports
- n.a. 11303BNXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID2 reports
- n.a. 11302BD2Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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