Valleylab SEP6000NSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521750920), received between Dec 22, 2023 and Nov 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fire” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Fire; Fire

  ACCORDING TO THE REPORTER, FLAME CONCERNS; BOVIE PENCILS CATCHING ON FIRE.

  Patient problems: Insufficient Information

  MAUDE report 20621082 ↗
• MalfunctionNov 6, 2024Fire; Fire

  ACCORDING TO THE REPORTER, FLAME CONCERNS; BOVIE PENCILS CATCHING ON FIRE.

  Patient problems: Insufficient Information

  MAUDE report 20620663 ↗
• MalfunctionJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, SURGEON WAS HOLDING SURGICAL INSTRUMENT ON TISSUE. RESIDENT USING BOVIE ON TISSUE NEAR SURGEON INSTRUMENT. ELECTRO-CURRENT TRAVELLED TO SURGICAL INSTRUMENT AND BURNED SURGEON'S HAND RATHER THAT CAUTERIZING TISSUE IT WAS INTENDED FOR. IT WAS A FIRST DEGREE BURN WITH SIZE OF TWO MILLIMETERS. SURGEON STEPPED AWAY FROM STERILE FIELD, TOOK GOWN AND GLOVES OFF TO EXAMINE ANY INJURY. SURGEON REPORTED A SMALL MARKING ON SURGEON HAND, ALTHOUGH NO PAIN. SURGICAL INSTRUMENT REMOVED FROM FIELD AND SURGEON RE-GOWNED BACK INTO THE STERILE FIELD. CURRENTLY, THE SURGEON WAS FINE, COULD NOT SEE THE BURN THE FOLLOWING MORNING.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19499417 ↗
• MalfunctionDec 22, 2023Self-Activation or Keying; Failure to Cut; Self-Activation or Keying; Failure to Cut

  ACCORDING TO THE REPORTER, WHEN A SMOKE EVACUATION BOVIE PENCIL WAS PLUGGED INTO A BOVIE MACHINE, THE 'CUT' FUNCTION WAS CONTINUOUSLY ACTIVATED DESPITE NO ONE PRESSING THE CUT BUTTON NOR WAS THE PENCIL PRESSING AGAINST ANYTHING. AFTER THE BOVIE MACHINE WAS TURNED OFF AND ON, THE PENCIL WAS PLUGGED IN AGAIN, AND THE CUT FUNCTION WAS AUTOMATICALLY ACTIVATED AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388013 ↗