Valleylab VLFT10FXGENRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521829527), received between Jan 31, 2025 and Mar 21, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EXCISION OF BASAL CELL CARCINOMA LESION ON THE RIGHT TEMPLE AREA OF THE PATIENT, THE PATIENT SUFFERED SUPERFICIAL BURNS DUE TO A FIRE. WHEN THE PATIENT WAS PLACED ON THE OPERATING TABLE, THE PATIENT RECEIVED LOW FLOW OXYGEN BY VENTIMASK. THE SURGEON INJECTED LIDOCAINE TO INCISION LINE. SURGEON USED CAUTERY TO BEGIN EXCISION OF SKIN CANCER. AFTER USING THE CAUTERY FOR THE INITIAL INCISION, A FIRE BROKE OUT IN THE VICINITY OF THE DRAPE AND VENTIMASK. IMMEDIATELY THE VENTIMASK WAS REMOVED AND THE OXYGEN WAS SHUT OFF. THE FIRE WAS QUICKLY EXTINGUISHED. ALL EQUIPMENT THAT WAS USED WERE REMOVED. SURGERY CONTINUED WITH NEW BOVIE, DRAPE AND INSTRUMENTATION. THE LESION OF CONCERN WAS REMOVED AND SENT FOR FROZEN SECTION UNTIL ALL MARGINS WERE CLEAR. BACITRACIN OINTMENT WAS APPLIED TO THE FACIAL BURN. THE PATIENT WAS DISCHARGED TO HOME IN GOOD CONDITION WITH PRESCRIPTIONS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21662430 ↗
• MalfunctionJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SURGEON WAS WORKING ON THE HEAD AREA AND IT GOT BURNT. PATIENT HAD TO GO TO OR AFTER SURGERY TO TAKE CARE OF IT.

  Patient problems: Burn(s)

  MAUDE report 21285099 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING EXCISION LESION RIGHT TEMPLE UNDER MODERATE SEDATION, THE DOCTOR WAS REMOVING LESION USING NEEDLE TIP CAUTERY. SCRUB TECH STATED THAT THEY SAW A SPARK ¿JUMP¿ FROM THE CAUTERY TO THE DRAPE ON THE PATIENT¿S LEFT SIDE. THE DRAPE IGNITED, AND IMMEDIATELY THE STAFF AND SURGEON PULLED ALL DRAPES OFF THE PATIENT. PATIENT RECEIVED BURNS TO FOREHEAD AND LEFT CHEEK AREA. THE PATIENT WAS SENT TO THE ER (EMERGENCY ROOM) AFTER THE INITIAL PROCEDURE. AN INTERVENTION WAS NEEDED, AND THE PATIENT WAS REFERRED TO THE WOUND CENTER FOR A FOLLOW UP. ER (EMERGENCY ROOM) DOCTOR NOTED THE BURNS TO BE ¿PARTIAL THICKNESS, WITH NO AIRWAY OR OCULAR INVOLVEMENT.¿

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21283193 ↗