DYONICS 7205396SRecalls & reported problems
Smith & Nephew, Inc. · EP-1 POWER FOOTSWITCH, PEDAL-STYLE, ON/OFF, 12 FEET 3.6 M CORD, SERVICE · Class 2
All models of DYONICS (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010251978), received between Feb 1, 2018 and Jan 6, 2019 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Sticking” (4 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 16, 2026.
Most reported problems
Device problems
- Sticking4
- Display or Visual Feedback Problem1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2019Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE SHAVER KEEPS RUNNING. A HANDPIECE ERROR MESSAGE DID NOT OCCUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP DEVICE, DELAY IN THE CASE OR PATIENT INJURY WERE NOT REPORTED. REVISION SURGERY WAS NOT PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8220873 ↗MalfunctionSep 20, 2018Physical Resistance/Sticking
IT WAS REPORTED THAT ONE OF THE PEDALS WAS NOT WORKING PROPERLY, IT WAS STUCK. AS PER THE CUSTOMER RESPONSE THIS ISSUE CAUSE THAT THE DEVICE RUN CONTINUOUSLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894313 ↗MalfunctionMay 22, 2018Sticking
IT WAS REPORTED THAT THE LEFT PEDAL IS STICKY, CAUSING THE SHAVER TO RUN CONTINUOUSLY. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7535256 ↗MalfunctionMay 21, 2018Sticking
IT WAS REPORTED THAT THE FOOTSWITCH WAS STICKING, CAUSING THAT THE SHAVER BLADE WAS RUNNING CONTINUOUSLY. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7530013 ↗MalfunctionFeb 28, 2018Sticking
IT WAS REPORTED THAT THE FOOT PEDAL WAS STICKY, THEY PULLED THE SHAVER OUT OF THE KNEE AND IT WAS STILL RUNNING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7303424 ↗MalfunctionFeb 1, 2018Sticking
IT WAS REPORTED THAT THE SHAVER PEDAL WOULD GET STUCK IN THE ON POSITION AND KEEP RUNNING WHILE INSIDE THE JOINT. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7234089 ↗
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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