DYONICS POWER II 72200873Recalls & reported problems

Summary

The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 03596010607409), received between Aug 18, 2017 and Jan 13, 2026 — classified as 12 injuries, 244 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (79 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Overheating of Device

  IT WAS REPORTED THAT, BEFORE SURGERY, IT WAS NOTICED THAT THE HANDLE OF A HANDPIECE WAS HOT AND COULD NOT BE USED. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK UP PRODUCT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053117 ↗
• MalfunctionOct 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, DII CONTROLLER WAS CONNECTED AND A SYSTEM ERROR APPEARED ON THE SCREEN. IT DIDN'T ALLOW TO SELECT "OK" AND DIDN'T RECOGNIZE THE HANDPIECE OR THE FOOT PEDAL. THE PROCEDURE WAS CANCELLED AFTER 30 MINUTES OF BEING STARTED, AND HAD TO BE RESCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367432 ↗
• MalfunctionAug 26, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE DURING AN ACL PROCEDURE, DII CONTROLLER WAS NOT GETTING ON. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901048 ↗
• MalfunctionAug 4, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DII CONTROLLER´S RPM WAS NOT REACHING THE DESIRE RANGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 22700164 ↗
• InjuryJun 30, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF SMALL JOINTS HAND, THE DII CONTROLLER LIT UP GREEN WITH THE WORD SETTINGS BUT ENGINE DID NOT TURN ON. THE ENGINE COULD BE HEARD TRYING TO START, BUT THE FORCE WAS NOT ENOUGH. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE TO AN OPEN PROCEDURE, THERE WAS A DELAY GREATER THAN 30 MINUTES. LONGER TURNSTILE TIME WAS REPORTED BUT NO DAMAGE CAUSED OR FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355240 ↗
• MalfunctionMay 5, 2025Computer Software Problem; Noise, Audible; Computer Software Problem; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DII CONTROLLER WAS MAKING A STRANGE NOISE AND THE SCREEN DID NOT DISPLAY ANY PORTS, WAS ONLY DISPLAYING THE SMITH LOGO WHEN THE CONTROLLER WAS TURN ON. AS A RESULT, THE PROCEDURE WAS CANCELLED; THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964728 ↗
• MalfunctionFeb 12, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DII CONTROLLER POWERED OFF AND DID NOT SWITCH BACK ON. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366770 ↗
• MalfunctionOct 10, 2024Communication or Transmission Problem; Insufficient Device Problem Information; Communication or Transmission Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DII CONTROLLER FOOTSWITCH AND HAND CONTROL OVERRIDE WERE NOT FUNCTIONING PROPERLY, AND THE TOUCH PANEL WAS NOT RESPONDING. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422966 ↗
• MalfunctionSep 3, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN TURNING ON THE DII CONTROLLER A "SHORT CIRCUIT DETECTED" ERROR WAS FOUND. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131510 ↗
• MalfunctionJun 7, 2024Failure to Shut Off; Physical Resistance/Sticking; Failure to Shut Off; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE POWER BUTTON OF THE DYONICS II CONTROLLER WAS STUCK IN THE ON POSITION AND IT COULD NOT BE POWERED OFF. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490893 ↗
• MalfunctionMay 26, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE DYONICS II CONTROLLER WAS ACTING WEIRD, WOULD GO ALL WAY DOWN TO THE LOWEST SETTING AND THEN IT WOULD GO OVER, IT WOULD MANUALLY TURN IT BACK UP TO HIGHEST SETTING AND SHORTLY AFTER IT WOULD GO ALL THE WAY BACK DOWN. IT WAS ON THE ¿ON/OFF¿ SETTING AND NOT VARIABLE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399194 ↗
• MalfunctionMar 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DII CONTROLLER PORT A WAS NOT WORKING. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. 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 18941320 ↗
• MalfunctionFeb 26, 2024Device Emits Odor; Smoking; Electrical Shorting; Device Emits Odor; Smoking; Electrical Shorting

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE DII CONTROLLER HAD SMOKE AND A BURNING SMELL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777865 ↗
• MalfunctionFeb 5, 2024Failure to Power Up; Arcing; Failure to Power Up; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE DII CONTROLLER COULD NOT BE ON AND THERE WAS A SPARK. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639730 ↗
• MalfunctionJan 30, 2024Overheating of Device; Electrical Shorting; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT DURING SET UP, THE DII CONTROLLER HAD A SHORTAGE ISSUE. THE SHORTAGE RESULTED IN OVERHEATING OF THE DEVICE. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607760 ↗
• MalfunctionJan 26, 2024Overheating of Device; Electrical Shorting; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT DURING SET UP FOR A KNEE ARTHROSCOPY, THE DYONICS II CONTROLLER HAD A SHORTAGE ISSUE WHICH RESULT OF AN OVERHEATED DEVICE. 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 18587954 ↗
• MalfunctionJan 8, 2024Overheating of Device; Electrical Shorting; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT DURING A PROCEDURE, A DII CONTROLLER´S HANDLE WAS OVERHEATING AND THE DEVICE GAVE AN "SHORT CIRCUIT" ERROR MESSAGE. NO DAMAGE TO THE USER NOR THE PATIENT AS A RESULT OF THE OVERHEAT WAS REPORTED. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469140 ↗
• MalfunctionSep 29, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE DII CONTROLLER CIRCUITED AND STARTED SMOKING. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A COMPETITOR BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843965 ↗
• MalfunctionSep 11, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE DII CONTROLLER SHOWED COLOR BARS AS SOON AS SWITCH ON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A COMPETITORS DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726632 ↗
• MalfunctionAug 21, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE DII CONTROLLER WAS NEEDED TO PLANARIZE THE KNEE, BUT IT WAS DISCOVERED THAT IT HAD NO POWER INPUT. THE SURGERY WAS STOPPED TEMPORARILY FOR AN HOUR, AND THE PATIENT WAS UNDER ANESTHESIA THE EXTENDED TIME. 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 17585392 ↗
• MalfunctionAug 16, 2023Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT, DURING A KNEE SCOPE. WHEN TA MOTOR DRIVE UNIT WAS PLUGGED INTO THE DII CONTROLLER, THE DII CONTROLLER WAS CAUSING THE HANDPIECE BECAME HOT. SURGERY WAS COMPLETED AFTER A 5-MINUTE DELAY USING A BACK-UP DEVICE INSTEAD. THE HANDPIECE WAS LATER TESTED IN ANOTHER DII CONTROLLER AND IT WORKED FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560969 ↗
• MalfunctionJun 20, 2023Smoking; Arcing; Smoking; Arcing

  IT WAS REPORTED THAT, DURING SET UP FOR A KNEE SCOPE WHEN THE DII CONTROLLER WAS TURNED ON, THERE WAS A SPARK IN THE BACK OF THE UNIT AND SMELL OF SMOKE. THE PROCEDURE WAS CARRIED OUT WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165908 ↗
• MalfunctionJun 19, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE DII CONTROLLER HAD A SHORT CIRCUIT AND CREATED SMOKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153032 ↗
• MalfunctionJun 7, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE DII CONTROLLER HAD A PROBLEM WITH THE SHAVER, IT GOT BURNED, THE DISPOSABLE TIP OF THE SHAVER GOT VERY HOT. THERE WAS NO SPARKS, SMOKE OR ARCING. THERE WAS NO DAMAGED OR BURNED CAUSED TO THE PATIENT/USER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083546 ↗
• MalfunctionJun 1, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, A DII CONTROLLER (B)(4) WAS EMITTING SMOKE FROM ITS BACK, WHICH WAS NOTICED BY THE NURSE, THIS LED THE NURSE TO SWITCH OFF EVERYTHING RIGHT AWAY. NO DAMAGE WERE CAUSED TO THE USER OR PATIENT AS A RESULT OF THE REPORTED ISSUE. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043757 ↗