Valleylab E2516Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884524000510), received between May 22, 2018 and Jun 30, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Arcing” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE'S COAG BUTTON WAS STUCK AND IT ACTIVATED AUTOMATICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357963 ↗
• InjuryMar 15, 2023Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem; Self-Activation or Keying; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, EACH TIME THE BOVIE PENCIL WAS PLACED ON THE PATIENT ABDOMEN, IT WENT INTO CUT MODE U NTOUCHED, AND IT ACTIVATED TWICE WITHOUT THE ACTIVATION BUTTON OR SWITCH BEING PUSHED. THERE WERE TWO PATIENT BURNS AND A MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.

  Patient problems: Burn(s)

  MAUDE report 16548109 ↗
• MalfunctionApr 15, 2022Melted; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Melted; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STERILE GOWN WAS BURNED BY THE BOVIE TIP WHILE ON FIELD BUT WAS NOT IN USE. THE GOWN WAS CHANGED ALONG WITH THE GLOVES. THE BOVIE TIP WAS SWITCHED OUT TO A COATED TIP AND CHANGED THE CUT SETTINGS FROM PURE TO BLEND. AFTER A FEW MINUTES OF USE, IT WAS NOTED THAT THE COATED TEFLON TIP APPEARED TO BE MELTING DUE TO THE HEAT OF THE BOVIE. A NEW BOVIE MACHINE, BOVIE PENCIL, TIP, AND GROUNDING PAD WERE USED WITH NO FURTHER ISSUES NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119060 ↗
• MalfunctionMar 31, 2020Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, THE BOVIE SPARKED AND CAUGHT ON FIRE.

  Patient problems: No Information

  MAUDE report 9907850 ↗
• MalfunctionDec 22, 2019Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING RIGHT GROIN EXPLORATION WITH PLASTICS CLOSURE, THE PENCIL WAS BEING USED BY THE PLASTIC SURGERY TEAM. THEY SET IT DOWN AND THE MACHINE STARTED RUNNING ON ITS OWN. WHEN LOOKING AT THE MACHINE, THE COAGULATION NUMBERS KEPT CHANGING ON THEIR OWN AND EXTREMELY HIGH IN THE HIGH 100S. IT WOULD NOT STOP RUNNING UNTIL WAS TURNED IT OFF. WHEN TURNED BACK ON, THE PENCIL WOULD NOT ALLOW TO ADJUST ANY NUMBERS AND ONCE AGAIN WAS SHOWING NUMBERS IN THE HIGH 100S. MACHINE WAS TAKEN OUT OF SERVICE. THE PATIENT SUFFERED A BURN THAT WAS THE LENGTH AND WIDTH OF A PENCIL TIP. APPROXIMATELY 2 CENTIMETERS IN LENGTH AND 2 MILLIMETERS IN WIDTH.

  Patient problems: Burn(s)

  MAUDE report 9508744 ↗
• MalfunctionDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE PATIENT HAD A BURN.

  Patient problems: Burn(s)

  MAUDE report 9452985 ↗
• MalfunctionFeb 12, 2019Fire; Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS THE FIRST PENCIL THAT WERE FLAMES COMING FROM IT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Information

  MAUDE report 8331128 ↗
• MalfunctionMay 22, 2018Arcing; Flare or Flash; Arcing; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PENCIL WAS ACTIVATED, RATHER THAN DELIVERING ENERGY FROM THE ELECTRODE TIP, AN ENERGY SPARKED TO THE PATIENT FROM WHERE THE ELECTRODE INSERTS TO THE PENCIL. THE PATIENT INCURRED A TEMPORARY INJURY, SMALL PENCIL ERASER SIZE BURN TO CHEST. ALTERNATE PENCIL AND ELECTRODE PULLED TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 7531554 ↗