COLORADO N103ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540004093), received between Jun 21, 2016 and Oct 26, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE FACILITY THAT UPON INSPECTION OF THE DEVICE, A HAIR WAS FOUND WITHIN THE STERILE PACKAGING. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017281 ↗
• MalfunctionMar 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THE NEEDLE BROKE OFF INTO THE PATIENT AND THE TIP COULD NOT BE LOCATED DUE TO SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16610244 ↗
• InjuryOct 17, 2022Degraded; Degraded

  IT WAS REPORTED THAT WHILE USING THE DEVICE DURING THE PROCEDURE, THE ELECTRODE BURNED THE NASAL MUCOSA OF HE PATIENT, CAUSING A SMALL WOUND. THE PATIENT WAS CHECKED FOR INJURY AND DISINFECTED AND A NEW ELECTRODE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15620719 ↗
• MalfunctionAug 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE RESECTION OF THE LEFT PAROTID GLAND TUMOR, THE SKIN WAS CUT WITH A MICRO ANATOMICAL TUNGSTEN NEEDLE COMBINED WITH AN ULTRASONIC KNIFE TO CUT AND REMOVE THE TUMOR. IT WAS NOTICED AFTER THE INCISION WAS CLOSED THAT THE TIP OF THE NEEDLE WAS FOUND TO BE 0.5MM SHORT.

  Patient problems: Insufficient Information

  MAUDE report 12263097 ↗
• MalfunctionJun 5, 2020Fracture; Fracture

  IT WAS REPORTED BY A DISTRIBUTOR THAT IN A MEDICAL PROCEDURE THE TIP OF THE DEVICE BROKE DURING SKIN INCISION. THE FRAGMENT WAS NOT FOUND IN A POST-OP CT OF THE PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 5 MINUTES, AND THAT THERE ARE NOT ANY POST-OP SYMPTOMS FOR THE PATIENT.

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

  MAUDE report 10124656 ↗
• InjuryNov 29, 2018Fire; Sparking

  IT WAS REPORTED THAT DURING AN OPHTHALMOLOGY CASE TO REPAIR PTOSIS OF THE LEFT UPPER EYELID, A SPARK AND FIRE WAS NOTED TO COME FROM THE CAUTERY PENCIL AT THE JUNCTION WHERE THE CAUTERY NEEDLE CONNECTS INTO THE CAUTERY PENCIL. WET GUAZE WAS IMMEDIATELY PLACED OVER THE EYE WHICH EXTINGUISHED THE FIRE. THE FIRE BURNED THE PATIENT'S EYELASHES, BUT NO SKIN OR OTHER AREAS WERE BURNED. THE STAFF AND PHYSICIAN WERE UNHARMED. SUPPLEMENTAL OXYGEN WAS NOT BEING USED.

  Patient problems: Burn, Thermal

  MAUDE report 8118354 ↗
• MalfunctionJun 21, 2016Device Contamination with Chemical or Other Material

  DURING IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (KIND OF FIBER OR HAIR) IN THE PACKAGE. THIS EVENT WAS FOUND ON 1 OF 20 UNITS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5739997 ↗