DYONICS, POWERMAX, ELITE 72200872SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010653703), received between May 31, 2017 and Dec 2, 2021 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT DID NOT WORK AND THE CORD GOT HOT. IT IS UNKNOWN WHEN THE EVENT OCCURRED RELATIVE TO SURGERY. BACK UP DEVICE AVAILABLE. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919914 ↗
• MalfunctionMar 3, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT SHOWED A SENSOR ERROR. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11404463 ↗
• MalfunctionDec 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT HAD AN UNSPECIFIED FUNCTIONAL FAILURE. INCIDENT OCCURRED DURING SET UP/INSPECTION OF THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A MOTOR BLOCKED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11016986 ↗
• MalfunctionOct 5, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SHAVER OF THE MDU WAS STALLED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 10626244 ↗
• MalfunctionOct 4, 2020Unintended Power Up; Overheating of Device; Unintended Power Up; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP FOR A SHOULDER SCOPE THE HANDPIECE WOULD CONTINUE RUNNING AFTER BUTTONS OR FOOT PEDAL WERE NO LONGER BEING USED. THE HANDPIECE STARTED TO FEEL HOT TO THE TOUCH. ANOTHER HANDPIECE WAS SWITCHED OUT AND THE CASE WAS ABLE TO CONTINUE WITHOUT DELAY OR INJURY TO PATIENT. 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 10624636 ↗
• MalfunctionJun 12, 2018Overheating of Device

  IT WAS REPORTED THAT THE SHAVER HANDLE BECAME HOT WHEN PLUGGED IN. IT WAS IMMEDIATELY REPLACED. NO DELAY TO THE CASE OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594424 ↗
• InjuryMay 22, 2018Overheating of Device; Smoking

  IT WAS REPORTED AN OVERHEATING OF THE DEVICE. THE CORD SMOKED DURING THE CASE, IT WAS PROMPTLY EXCHANGED WITH ANOTHER ONE. THERE WAS NO PATIENT HARM OR INJURY, IT ONLY DELAYED THE CASE LONG ENOUGH TO GET THE OTHER SHAVER. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH A MINOR DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531700 ↗
• MalfunctionMay 15, 2018Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS RUNNING HOT. NO CASE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515495 ↗
• MalfunctionJan 30, 2018Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE MDU WAS OVERHEATING AND MAKING GRINDING NOISES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228229 ↗
• MalfunctionJan 30, 2018Overheating of Device; Smoking

  IT WAS REPORTED THAT THE DEVICE GOT HOT, THE UNIT WAS THEN UNPLUGGED AND THEN IT STARTED SMOKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7227926 ↗
• MalfunctionJan 19, 2018Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS OVERHEATING. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7206147 ↗
• MalfunctionJan 11, 2018Sticking

  IT WAS REPORTED THAT THE BUTTON GOT STUCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7182001 ↗
• MalfunctionDec 28, 2017Overheating of Device; Device Inoperable

  IT WAS REPORTED THAT THE HANDPIECE WAS GETTING WARM AND STOPPED WORKING. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151631 ↗
• MalfunctionNov 17, 2017Temperature Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT WORK, HEATED UP DURING THE CASE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040372 ↗
• MalfunctionNov 2, 2017Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HEATING UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995578 ↗
• MalfunctionOct 26, 2017Overheating of Device

  IT WAS REPORTED DEVICE HANDLE GOT VERY HOT. NO INJURIES OR DELAY REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6981392 ↗
• MalfunctionAug 3, 2017Self-Activation or Keying

  IT WAS REPORTED THE POWERMAX ELITE MDU HAND CONTROL TURNS ON BY ITSELF. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762982 ↗
• MalfunctionMay 31, 2017Mechanical Problem; Overheating of Device; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE MDU LOCKED UP AND BECAME WARM PRIOR TO THE PROCEDURE. A BACKUP DEVICE WAS USED TO PERFORM AND COMPLETE THE PROCEDURE. NO INJURIES OR COMPLICATIONS WERE NOTED AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6601661 ↗