DYONICS 72204114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554033458), received between Jan 11, 2018 and Mar 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2021Failure to Shut Off; Physical Resistance/Sticking; Failure to Shut Off; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A FOOT SURGERY, THE FORWARD BUTTON OF THE DYONICS HANDPIECE WAS STICKY BUT WHEN IT WAS RELEASED THE HANDPIECE DID NOT SHUT OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 11404873 ↗
• MalfunctionJan 11, 2018Power Conditioning Problem

  IT WAS REPORTED THAT THE DEVICE HAD NOT ENOUGH POWER. PROCEDURE HAD TO BE COMPLETED WITH A COMPETITOR DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181795 ↗