NA F7244Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18033695727142), received between Feb 3, 2021 and Oct 12, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Flare or Flash” (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.

• InjuryOct 12, 2023Material Fragmentation; Material Fragmentation

  DESCRIPTION OF THE REPORTING HEALTHCARE FACILITY FROM THE REPORT DATED 09/26/2023; "THE DEVICE WAS USED TO PIERCE THE FINGERNAIL OF A PATIENT'S RIGHT HAND AND DRAIN THE SUBUNGUAL HEMATOMA. DURING THE NAIL PIERCING PROCEDURE, THE TIP OF THE ELECTROCAUTERY BROKE OFF AND REMAINED LODGED IN THE FINGER OF THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 17919645 ↗
• InjuryFeb 3, 2021Flare or Flash; Flare or Flash

  INDICATION FOR SURGERY: REMOVAL OF A RECURRENT CUTANEOPALPEBRAL LESION LOCATED IN THE LEFT INTERNAL CORNER, UNDER GENERAL ANESTHESIA WITH SPONTANEOUS VENTILATION AND PLACEMENT OF O2 NASAL CANNULA. THE NASAL REGION WAS COVERED WITH A SURGICAL MASK AND THEN WITH A SURGICAL DRAPE AND AN OPHTHALMOLOGICAL DRAPE LEAVING ONLY THE LEFT ORBITAL REGION UNCOVERED. AT THE END OF THE OPERATION, DURING THE CAUTERIZATION OF THE SURGICAL AREA WITH THE CAUTERY, A FLAME SUDDENLY FORMED, BURNING THE EYELASHES AT THE LEVEL OF THE UPPER AND LOWER EYELID (PALPEBRAL SLIT CLOSED). FLAME WAS EXTINGUISHED BY THE PHYSICIAN. A SECOND DEGREE BURN PARTIALLY AFFECTED THE SKIN OF THE UPPER EYELID. THE EYELASHES WERE BURNT. AT THE OPENING OF THE EYELID, A CENTRAL BURN, FROM LIMBUS TO LIMBUS WAS NOTED ON THE CORNEA. INITIAL TREATMENT WITH SALINE SOLUTION WASHING OF THE NECROTIC AND BLEACHED CORNEAL EPITHELIUM SHOWING A CLEAR AND TRANSPARENT UNDERLYING STROMA. TREATMENT THEN INCLUDED APPLICATION OF ANTIBIOTIC EYE OINTMENT COMBINED WITH AN EYE PATCH AND SYSTEMIC PAIN RELIEVERS. HOSPITALIZATION OF 48 HOURS WAS NECESSARY FOR TREATMENT WITH LOCAL OINTMENTS EVERY HOUR AND MONITORING OF HEALING. VISUAL ACUITY WAS CALCULAT

  Patient problems: Eye Burn

  MAUDE report 11273968 ↗