COLORADO N104ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540004116), received between Jul 1, 2020 and Feb 26, 2021 — classified as 1 injury, 1 malfunction.

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

• InjuryFeb 26, 2021Sparking; Sparking

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON USED THE COLORADO NEEDLE ALONG WITH THE BOVIE ON THE PATIENT¿S LEFT CHEEK AND THE BOVIE SPARKED WHILE IN USE AND LIT THE DRY COTTON BALL, PLACED IN PATIENTS EAR, ON FIRE. THERE WAS A SALINE QUICKLY POURED OVER TO EXTINGUISH THE FLAME. PATIENT¿S LEFT EAR WAS NOTED TO BE RED AND AN ANTIBIOTIC OINTMENT WAS PUT ON IT. THERE IS NO OTHER INFORMATION KNOWN AT THIS TIME.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 11388783 ↗
• MalfunctionJul 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE WHEN USING THE COLORADO NEEDLE INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED USING A BACKUP COLORADO NEEDLE, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10219444 ↗