DYONICS 7205396Recalls & reported problems
Smith & Nephew, Inc. · EP-1 POWER FOOTSWITCH, PEDAL-STYLE, ON/OFF · Class 2
Quick summary
This Smith & Nephew EP-1 power footswitch is a pedal-style on/off foot control used to run the arthroscopy shaver during knee and shoulder procedures. The 28 reports mostly describe a pedal that sticks or stays pressed, so the shaver keeps running after the surgeon lifts their foot or won't shut off. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010251961), received between Feb 12, 2018 and Jun 22, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (11 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
- Physical Resistance/Sticking11
- Failure to Shut Off3
- Mechanical Jam3
- Device Operates Differently Than Expected2
- Electrical /Electronic Property Problem2
- Self-Activation or Keying2
- Therapeutic or Diagnostic Output Failure2
- Unintended Power Up2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient11
- No Patient Involvement4
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE LEFT FOOT OF THE FOOTSWITCH STUCK, NOT ALLOWING THE SHAVER TO TURN OFF AFTER USAGE. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS A ONE-MINUTE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304619 ↗MalfunctionSep 5, 2024Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE FOOTSWITCH MADE THE SHAVER HANDPIECE RUN CONTINUOUSLY EVEN IF IT WAS NOT PRESSED DOWN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20151477 ↗MalfunctionSep 26, 2023Physical Resistance/Sticking; Activation Problem; Physical Resistance/Sticking; Activation Problem
IT WAS REPORTED THAT DURING SET UP OF A SHOULDER ARTHROSCOPY, THE FOOTSWITCH PEDAL WAS STUCK DOWN AND THE SHAVER WAS IN REVERSE THE WHOLE TIME THERE WAS A BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821156 ↗MalfunctionJun 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY , THE FOOTSWITCH, EP-1, PEDAL STYLE HAD A STICKY PEDAL, IT STAYED DOWN WHEN THE FOOT WAS TAKEN OFF. THE SHAVER WOULD STAY ENGAGED UNTIL THE PEDAL WAS RELEASED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136277 ↗MalfunctionOct 20, 2022Failure to Shut Off; Failure to Shut Off
IT WAS REPORTED THAT, DURING SET UP, THE FOOTSWITCH ACTIVATED THE SHAVER WHEN IT WAS PLUGGED IN AND WOULDN'T TURN IT OFF UNLESS PEDAL WAS UNPLUGGED. THE FOOTSWITCH WAS PLUGGED IN AGAIN AND GOT FOOT PEDAL ERROR MESSAGE. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15637465 ↗MalfunctionJan 17, 2022Unintended Power Up; Physical Resistance/Sticking; Unintended Power Up; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PEDAL BUTTON OF THE FOOTSWITCH GOT STUCK IN FORWARD AND WOULD NOT STOP. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13265993 ↗MalfunctionDec 1, 2021Failure to Shut Off; Failure to Shut Off
IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, WHEN PLUGGING THE FOOTSWITCH, THE HANDPIECE CONTINUED TO RUN NONSTOP. BACK UP DEVICE WAS AVAILABLE. NO DELAYS NOR PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12911542 ↗MalfunctionOct 4, 2021Unintended Power Up; Physical Resistance/Sticking; Unintended Power Up; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING SHOULDER ROTATOR CUFF ARTHROSCOPY, THE FORWARD BUTTON OF THE FOOTSWITCH, EP-1, PEDAL STYLE GOT STUCK, SO THE SHAVER WAS ALWAYS ON. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (LESS OR EQUAL TO 30MIN), WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12571701 ↗MalfunctionOct 3, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE FOOTSWITCH WAS STICKING AND MAKING THE UNIT TO RUN CONTINUOUSLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12566622 ↗MalfunctionOct 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE FOOTSWITCH WAS STICKING AND MAKING THE UNIT TO RUN CONTINUOUSLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565905 ↗MalfunctionJul 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SET UP FOR A KNEE SCOPE, THE FOOT PEDAL WAS STICKING. THE STICKING ISSUE CAUSE THE DEVICE TO RUN UNINTENDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12131760 ↗MalfunctionMar 13, 2021Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT, DURING SET UP FOR AN UNKNOWN PROCEDURE, THE FOOTSWITCH STOPPED WORKING, IT STOPPED COMMUNICATING WITH THE SHAVER BOX. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478531 ↗MalfunctionJan 5, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FOOTSWITCH DID NOT OSCILLATE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11116842 ↗MalfunctionAug 10, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING THE PROCEDURE THE FOOTSWITCH WAS BROKEN. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT BOTH PEDALS OF THE FOOTSWITCH WHERE STUCK IN THE DEPRESSED POSITION WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10389017 ↗MalfunctionJun 3, 2019Electrical Shorting; Electrical Shorting; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE FOOTSWITCH MAY HAVE A SHORT. IT WOULD NOT WORK CONSISTENTLY WHEN STEPPING ON THE FOOT PEDAL. NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8664862 ↗MalfunctionApr 15, 2019Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT BEFORE THE SURGERY THE DEVICE JUST KEEPS CYCLING. NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8515982 ↗MalfunctionMar 28, 2019Self-Activation or Keying
IT WAS REPORTED THAT DURING A HIP SCOPE SURGERY THE RIGHT PEDAL LOCKS UP, THIS ISSUE CAUSED THE DEVICE TO CONTINUALLY RUN UNINTENDED. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8459711 ↗MalfunctionMar 12, 2019Failure to Shut Off
IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE DEVICE RANDOMLY TURNED ON THE SHAVING WHEN IT WAS NOT BEING PRESSED, IT WOULD NOT BE TURN OFF. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8415172 ↗MalfunctionFeb 19, 2019Sparking
IT WAS REPORTED THAT THE FOOTSWITCH SPARKED WHEN IT WAS PLUGGED INTO THE DII CONTROLLER. NO CASE INVOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8351554 ↗MalfunctionFeb 19, 2019Physical Resistance/Sticking
IT WAS REPORTED THAT THE REVERSE PEDAL WAS STUCK CAUSING CONTINUALLY RUN. NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8349442 ↗MalfunctionFeb 15, 2019Physical Resistance/Sticking
IT WAS REPORTED THAT THE PEDALS PERIODICALLY ARE STICKING CAUSING THE DEVICE TO CONTINUALLY RUN. NO CASE INVOLVED. NO USER INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8345764 ↗MalfunctionDec 1, 2018Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGERY, THE RIGHT SIDE PEDAL WAS STICKED CAUSING TO CONTINUALLY RUN UNINTENDEDLY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NEITHER SIGNIFICANT DELAY NOR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121871 ↗MalfunctionOct 31, 2018Mechanical Jam
IT WAS REPORTED THAT THE PEDAL WAS STUCK AND THE DEVICE RUN CONTINUOUSLY UNINTENDED. NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8026620 ↗MalfunctionJun 12, 2018Electrical /Electronic Property Problem
IT WAS REPORTED THAT FOOTSWITCH IS SHORTING OUT. THE EVENT OCCURRED DURING TESTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7594007 ↗MalfunctionMay 15, 2018Device Operates Differently Than Expected
IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY RUNNING, WON'T SHUT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7516653 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.