n.a. 20016230Recalls & reported problems
Karl Storz GmbH & Co. KG · One-Pedal Footswitch, analog, two-stage · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551274613), received between Apr 12, 2023 and Dec 13, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Sense” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Sense2
- Circuit Failure1
- Unintended Movement1
- Unintended Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE UROLOGIST HAD FINISHED ENUCLEATING THE PROSTATE AND WAS ABOUT TO USE THE MORCELLATOR BUT WHEN TESTING THE SYSTEM, THE FOOT PEDAL WOULDN'T ALLOW THE PINCH VALUE TO OPEN ON THE S-PILOT. PROCEDURE ABORTED AND THE PATIENT WILL STAY ON THE WARD UNTIL THE DEVICE IS READY TO USE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926939 ↗InjuryDec 13, 2024Circuit Failure; Failure to Sense; Circuit Failure; Failure to Sense
IT WAS REPORTED THAT THE UROLOGIST HAD FINISHED ENUCLEATING THE PROSTATE AND WAS ABOUT TO USE THE MORCELLATOR BUT WHEN TESTING THE SYSTEM, THE FOOT PEDAL WOULDN'T ALLOW THE PINCH VALUE TO OPEN ON THE S-PILOT. PROCEDURE ABORTED AND THE PATIENT WILL STAY ON THE WARD UNTIL THE DEVICE IS READY TO USE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926912 ↗InjuryApr 12, 2023Unintended Power Up; Unintended Movement; Unintended Power Up; Unintended Movement
THE EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT AFTER ENUCLEATION WITH A LASER, THE MORCELLATOR HAD TO BE USED. WE MADE THE CONNECTION JUST BEFORE ENTERING THE PATIENT WITH THE BLADE. THE BLADE BEGAN TO ROTATE WITHOUT ANY DRIVE. FINALLY, THE DOCTOR HAD TO PERFORM ANOTHER PROCEDURE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16724378 ↗
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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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