NA 72200873SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010615411), received between Dec 13, 2017 and May 5, 2026 — classified as 19 malfunctions.

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

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Electrical Shorting

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, A DYONICS CONTROL UNIT CAUSED THE POWER TO FAIL AND BLEW THE ELECTRICS UP. THE PATIENT HAD TO BE MOVED TO ANOTHER THEATRE FOR THE SURGERY TO CONTINUE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30-MIN, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084953 ↗
• MalfunctionOct 26, 2022Fire; Fire

  IT WAS REPORTED THAT, DURING SET UP, THE DYONICS POWER SYSTEM WAS PLUGGED INTO A STORZ CAMERA STACK AND IT MADE BANG AND SET FIRE TO THE STACK. A NON-SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674693 ↗
• MalfunctionOct 19, 2022Smoking; Smoking

  IT WAS REPORTED THAT DURING SETUP THE DYONICS POWER II STARTED SMOKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636084 ↗
• MalfunctionApr 23, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DYONICS POWER II CONTROL UNIT CAUGHT FIRE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. 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 11712814 ↗
• MalfunctionMar 30, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT HAD A "HANPIECE SENSOR FAULT" ERROR. 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 11587087 ↗
• MalfunctionMar 24, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DYONICS POWER II CONTROL UNIT WAS HOT. NO CASE REPORTED; THEREFORE THERE WAS NO PATIENT INVOLVED. 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 11560689 ↗
• MalfunctionMar 16, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DYONICS POWER II CONTROL UNIT HAD AN UNKNOWN HANDPIECE FAILURE WITH PORT A. 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 11498846 ↗
• MalfunctionMar 14, 2021Communication or Transmission Problem; Connection Problem; Communication or Transmission Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN UNKNOWN PROCEDURE THE PORT A IS NOT DRIVING THE HAND PIECE AND THE PORT B IS 90 DEGREES OFF IN THE DYONICS POWER II CONTROL UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 11479024 ↗
• MalfunctionDec 28, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE DYONICS POWER HAD A HANDPIECE SENSOR FAULT ERROR- PORT B. NO CASE WAS INVOLVED; 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 11083880 ↗
• MalfunctionSep 18, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE DYONICS WAS NOT WORKING. IT IS UNKNOWN IF THERE WAS A DELAY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION. RESULTS OF INVESTIGATION REVEALED THAT DURING FUNCTIONAL EVALUATION THE DEVICE DISPLAYED A HANDPIECE STALL ERROR 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 Information

  MAUDE report 10553324 ↗
• MalfunctionSep 18, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DYONICS WAS NOT WORKING. IT IS UNKNOWN IF THERE WAS A DELAY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A HAND PIECE STALL ERROR 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 Information

  MAUDE report 10553219 ↗
• MalfunctionAug 21, 2020Smoking; Smoking

  IT WAS REPORTED THAT WHEN THE CONTROL UNIT WAS PLUGGED IN SMOKE CAME OUT OF IT. NO CASE INVOLVED. 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 10439528 ↗
• MalfunctionJul 9, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE CONTROL UNIT WAS NOT TURNING ON. NO CASE INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT A HAND PIECE STALL ERROR MESSAGE 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 10251307 ↗
• MalfunctionMar 14, 2018Device Inoperable

  IT WAS REPORTED THAT THE PORT A WAS NOT WORKING, A SHORT CIRCUIT ERROR MESSAGE OCCURRED. NO USER INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337823 ↗
• MalfunctionJan 30, 2018Electrical Shorting

  IT WAS REPORTED BY CUSTOMER THAT DEVICE PRESENTED SHORT CIRCUIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227002 ↗
• MalfunctionJan 5, 2018Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE HAS A SHORT CIRCUIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7166923 ↗
• MalfunctionDec 22, 2017Connection Problem

  IT WAS REPORTED THAT BEFORE THE PROCEDURE THE CONNECTION PORT FOR SHAVER OF THE DYONICS POWER CONTROLLER IS HAVING ISSUES. NO PATIENT INJURY REPORTED. SUBSEQUENT INVESTIGATION RESULTS LATER REVEALED A BURNT PIN SOCKET IN PORT A AND PORT B BOTH GUIDE PINS ARE BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143997 ↗
• MalfunctionDec 20, 2017Overheating of Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE GOT HOT AND A HIGH VOLTAGE MESSAGE OCCURRED. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136360 ↗
• MalfunctionDec 13, 2017Overheating of Device; Smoking

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING, SHORT CIRCUIT AND SMOKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7113045 ↗