Valleylab SM VSMP15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521836365), received between Sep 2, 2025 and Apr 1, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (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 18, 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.

• MalfunctionApr 1, 2026Fire

  IT WAS REPORTED THAT DURING A BREAST PROCEDURE, THE DEVICES WERE INVOLVED IN A BRIEF OPEN FLAME AT THE DISTAL TIP OF THE ELECTRODE. THE PROCEDURE WAS MOMENTARILY PAUSED DUE TO THE SENTINEL EVENT INVOLVING THE OPEN FLAME. THE TECHNIQUE USED INVOLVED A METAL POINTED CLAMPING INSTRUMENT CLAMPED ONTO TISSUE, WITH THE ELECTRODE PLACED TOUCHING THE JAWS OF THE INSTRUMENT AND ACTIVATED, CAUSING THE ELECTRICAL CIRCUIT TO MOVE THROUGH THE JAWS TO THE TARGET TISSUE. AFTER THE ELECTRODE WAS REMOVED FROM THE INSTRUMENT, A FLAME BRIEFLY APPEARED AT THE DISTAL TIP AND THEN WENT AWAY QUICKLY. A NEW GENERATOR WAS RETRIEVED AND THE CASE RESUMED AFTER REPLACING THE ELECTRODE AND OPENING AN OLDER SMOKE EVAC PENCIL FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751610 ↗
• MalfunctionJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE, THE DEVICE BURNED THE HAND OF THE PHYSICIAN USING IT.

  Patient problems: Burn(s)

  MAUDE report 23973553 ↗
• InjurySep 2, 2025Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, POST-OPERATIVELY, THE UNIT SPARKED WHEN USING SUCTION CAUTERY PENCIL. PATIENT HAD BLEEDING IN THE PRIMARY TONSIL AND WAS BROUGHT BACK TO THE OPERATING ROOM FOR ADDITIONAL SURGERY TO CONTROL THE BLEEDING WITH A SUCTION COAGULATOR. THERE WAS NO IMAGING DONE. BLOOD TRANSFUSION WAS NOT NECESSARY. ANOTHER HANDPIECE WAS USED AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22936919 ↗