DYONICS 7209391SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010498014), received between Mar 28, 2018 and Aug 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DRILL FROZE AND GOT HOT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291493 ↗
• MalfunctionMay 28, 2018Failure to Shut Off

  IT WAS REPORTED THAT DRILL WOULD NOT SHUT OFF. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547775 ↗
• MalfunctionMar 28, 2018Overheating of Device; Device Stops Intermittently

  IT WAS REPORTED THAT DEVICE WORKS INTERMITTENTLY AND OVERHEATS. NO PATIENT OR USER INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7377497 ↗