n.a. 28162ZERecalls & reported problems
Karl Storz GmbH & Co. KG · Biopsy Forceps, 2.7 mm, 30 cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551098585), received between Aug 20, 2020 and Aug 20, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2020Material Separation; Material Separation
PER THE DOCTOR WHILE PERFORMING A BIOPSY FOR A INTRAVENTRICULAR BRAIN TUMOR, ON THE THIRD BIOPSY, THE FORCEPS WOULD NOT GRASP AND THE INSTRUMENT WAS REMOVED. MRI WAS DONE AND IT APPEARS TO BE A VERY SMALL GRANULAR PIECE REMAINED THERE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION TO THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10431068 ↗
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- 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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