n.a. 26046ARARecalls & reported problems
Karl Storz GmbH & Co. KG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551436271), received between Mar 30, 2026 and Mar 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Optical Distortion” (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. 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
- Optical Distortion3
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.
MalfunctionMar 30, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "POOR VISION UPON INSPECTION OF TELESCOPE DUE TO BROKEN INTERNAL ROD LENS. THIS TELESCOPE IS A COMPONENT IN A DEMO SET USED DURING A CLINICAL TRIAL ON A PATIENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723069 ↗MalfunctionMar 30, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "POOR VISION UPON INSPECTION OF TELESCOPE DUE TO BROKEN INTERNAL ROD LENS. THIS TELESCOPE IS A COMPONENT IN A DEMO SET USED DURING A CLINICAL TRIAL ON A PATIENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723060 ↗MalfunctionMar 30, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: POOR VISION UPON INSPECTION OF TELESCOPE DUE TO BROKEN INTERNAL ROD LENS. THIS TELESCOPE IS A COMPONENT IN A DEMO SET USED DURING A CLINICAL TRIAL ON A PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719557 ↗
Other Endoscope, neurological devices
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
- VS3-IR 161-0001Visionsense Ltd. · Endoscope, Neurological1 recall4 reports
- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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