NA 72201092Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 03596010607423), received between Jun 28, 2017 and May 15, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Self-Activation or Keying; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT, BEFORE SURGERY, IT WAS NOTICED THAT ONE (1) FOOTSWITCH DYONICS POWER II WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192925 ↗
• MalfunctionJan 6, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, ONE (1) DYONICS II FOOTSWITCH WAS MALFUNCTIONING, AND MIGHT BE STUCK, CAUSING THE HANDPIECE TO OSCILLATE CONTINUOUSLY INSTEAD OF WHEN THE SURGEON DESIRED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976911 ↗
• MalfunctionSep 10, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING SET UP, THE DYONICS POWER II FOOTSWITCH WAS PLUGGED IN, IT WAS TURNING ON THE HANDPIECE WITHOUT ANYONE STEPPING ON IT. 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 23018077 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Key or Button Unresponsive/not Working; Detachment of Device or Device Component; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING SETUP OR INSPECTION, THE BUTTONS OF THE FOOTSWITCH WERE NOT WORKING. A BACK-UP DEVICE WAS AVAILABLE, AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755349 ↗
• MalfunctionJan 29, 2025Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  IT WAS REPORTED THAT DURING SETUP, THE CORD OF THE FOOTSWITCH WAS DAMAGED, AND IT WARMED UP WHEN PLUGGED INTO THE BOX. A BACK-UP DEVICE WAS AVAILABLE, AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261688 ↗
• MalfunctionDec 2, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING A LEFT KNEE MENISCUS SHAPING SURGERY, THE FOOT PEDAL SUDDENLY BECAME UNUSABLE, THERE WAS NO RESPONSE WHEN IT WAS DEPRESSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT KNEE ARTHROSCOPY SURGICAL TECHNIQUE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820433 ↗
• MalfunctionOct 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE OSCILLATE PEDAL OF THE FOOTSWITCH WAS STUCK, THEREFORE, WHEN IT WAS PLUGGED IN, THE HANDPIECE JUST RUNS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490369 ↗
• MalfunctionOct 3, 2024Corroded; Failure to Shut Off; Corroded; Failure to Shut Off

  IT WAS REPORTED THAT, DURING SET UP, THE DYONICS FOOTSWITCH WOULD NOT STOP RUNNING THE SHAVER WHEN PLUGGED IN. THE SHAVER WAS RUNNING WITHOUT THE PEDAL BEING TOUCHED AND WOULD ONLY STOP WHEN THE PEDAL WAS UNPLUGGED. 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 20358740 ↗
• MalfunctionFeb 29, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE PLUG OF THE DYONICS FOOTSWITCH WARMED OFF. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809081 ↗
• MalfunctionFeb 26, 2024Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT AFTER THE DYONICS POWER II FOOTSWITCH WAS PLUGGED INTO THE SHAVER BOX, AND TURNED ON THE SHAVER TIP, IT WAS NOT TURNING OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784518 ↗
• MalfunctionJan 14, 2024Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  IT WAS REPORTED THAT DURING SET UP, THE DYONICS FOOTSWITCH WOULD NOT PLUG IN. ADDITIONALLY THE DEVICE WAS VERY HOT AND NOT RUNNING. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509826 ↗
• MalfunctionApr 21, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DYONICS FOOTSWITCH WAS OVERHEATING. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787537 ↗
• MalfunctionFeb 4, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE DYONICS POWER II FOOTSWITCH WAS TOO HOT, AND THE PLUG IN CABLE WAS CUT. NO DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300813 ↗
• MalfunctionFeb 1, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, A SPARK OCCURRED WHILE PREPARING THE FOOTSWITCH AND IT LEFT A MARK ON THE EXTERIOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279393 ↗
• MalfunctionJan 9, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE FOOTSWITCH EMITTED A SPARK WHILE AT USE. IT IS UNKNOWN IF 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 16122007 ↗
• MalfunctionJan 2, 2023Connection Problem; Electrical Shorting; Material Deformation; Connection Problem; Electrical Shorting; Material Deformation

  IT WAS REPORTED THAT, DURING SHOULDER SCOPE PROCEDURE, THE DYONICS POWER II FOOTSWITCH CORD WOULD NOT CONNECT TO THE MONITOR, IF APPEARED TO HAVE A SHORT AND GOT WARM. NO DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16083985 ↗
• MalfunctionDec 12, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE FOOTSWITCH WAS GETTING HOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963189 ↗
• MalfunctionSep 11, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE FOOTSWITCH WAS PLUGGED IN, THE SHAVER OPERATED IRRESPECTIVE OF THE PEDALS BEING PRESSED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397977 ↗
• MalfunctionJan 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ''FOOTSWITCH' BUTTONS WERE GETTING STUCK DOWN SO THE SURGEON COULD NOT STOP THE SHAVER. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. THERE WAS A BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169276 ↗
• MalfunctionOct 11, 2021Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THERE WAS A LOW INTENSITY ELECTRIC SHOCK WHILE USING THE DYONICS POWER II FOOTSWITCH. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606554 ↗
• MalfunctionJun 13, 2021Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT, THE DYONICS FOOTSWITCH HAD A SHORT IN THE WIRE. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY NOR PATIENT INJURY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989066 ↗
• MalfunctionJun 7, 2021Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT THE FOOT SWITCH DYONICS POWER MAKES THE SHAVER KEEP OPERATING WHEN THE PEDAL WAS NOT PRESSED. NO CASE INVOLVED. THEREFORE, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952888 ↗
• MalfunctionMay 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT IN A ROUTINE CHECK THE FOOTSWITCH DIDN¿T WORK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817094 ↗
• MalfunctionJul 15, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE GENERATOR WAS NOT RECOGNIZING WHEN A HANDPIECE WAS PLUGGED IN. 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 Patient Involvement

  MAUDE report 10277478 ↗
• MalfunctionJul 3, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOTSWITCH WAS NOT WORKING, WHEN THE FOOT PEDAL IS PRESSED NOTHING HAPPENS. 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 Patient Involvement

  MAUDE report 10230798 ↗