n.a. 11282BN1Recalls & reported problems
Karl Storz GmbH & Co. KG · Neuro-Fiberscope, 3.7 x 34 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551226476), received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED: THERE WAS FLAKING OF THE ENDOSCOPE TIP WITH THE RELEASE OF DEBRIS INSIDE THE VENTRICLE. THE FLEXIBLE ENDOSCOPE TIP COVER DISINTEGRATED, RELEASING SMALL FRAGMENTS DURING THE SURGERY. ACCORDING TO THE INFORMATION, THE CONSEQUENCES WERE AS FOLLOWS: SUSPENSION OF THE PROCEDURE, RESCHEDULING FOR A NEW SURGERY, AND THE NEED FOR INTRAVENOUS ANTIBIOTICS WITH CNS COVERAGE.
Patient problems: Insufficient Information
MAUDE report 21315334 ↗
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 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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