Valleylab E2516HGNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884524003016), received between Sep 7, 2017 and Dec 23, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fire” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fire; Fire

  IT WAS REPORTED THAT THE DEVICE BOVIE TIP CAUGHT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875407 ↗
• MalfunctionOct 28, 2025Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DELAY BETWEEN THE MACHINE AND THE CAUTERY PENCIL REACTION WHICH CAUSED HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 23404681 ↗
• MalfunctionOct 28, 2025Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DELAY BETWEEN THE MACHINE AND THE CAUTERY PENCIL REACTION WHICH CAUSED HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 23404606 ↗
• MalfunctionJul 24, 2025Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING USE, THE PENCIL AND THE ELECTRODE HAD FIRE INCIDENT. ARCHING HAD OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588517 ↗
• MalfunctionJun 3, 2025Fire; Arcing; Fire; Arcing

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, THE ELECTRODE TIP OF THE DEVICE WAS VISIBLY MELTED, AS ALSO SEEN IN THE PHOTO RECEIVED. IT WAS ALSO REPORTED THAT THE DEVICE SPARKED. THE SETTINGS ON THE FT10 UNIT AT THE TIME OF THE INCIDENT WERE BLEND AND FULGURATE POWER LEVEL OF 30 WATTS. ADDITIONALLY, TESTING WAS CONDUCTED WITH THE HOSPITAL'S BIOMED DEPARTMENT, TWO PENCILS AND TWO ELECTRODES CREATED SPARKS WHEN THE BLEND MODE ON THE FT10 WAS SET AT 100. IT WAS FURTHER REPORTED THAT A FLAME WITH THE SIZE OF A BIRTHDAY CANDLE WAS PRODUCED AND WAS EXTINGUISHED BY RELEASING OFF THE COAGULATION BUTTON. BIOMED TESTED THE GENERATOR AND IT WAS WITHIN SPECIFICATION AND WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135043 ↗
• MalfunctionJun 3, 2025Fire; Arcing; Fire; Arcing

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, THE ELECTRODE TIP OF THE DEVICE WAS VISIBLY MELTED, AS ALSO SEEN IN THE PHOTO RECEIVED. IT WAS ALSO REPORTED THAT THE DEVICE SPARKED. THE SETTINGS ON THE FT10 UNIT AT THE TIME OF THE INCIDENT WERE BLEND AND FULGURATE POWER LEVEL OF 30 WATTS. ADDITIONALLY, TESTING WAS CONDUCTED WITH THE HOSPITAL'S BIOMED DEPARTMENT, TWO PENCILS AND TWO ELECTRODES CREATED SPARKS WHEN THE BLEND MODE ON THE FT10 WAS SET AT 100. IT WAS FURTHER REPORTED THAT A FLAME WITH THE SIZE OF A BIRTHDAY CANDLE WAS PRODUCED AND WAS EXTINGUISHED BY RELEASING OFF THE COAGULATION BUTTON. BIOMED TESTED THE GENERATOR AND IT WAS WITHIN SPECIFICATION AND WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135029 ↗
• MalfunctionOct 24, 2024Fire; Arcing; Fire; Arcing

  ACCORDING TO THE REPORTER, DURING BILE DUCT TUMOR EXCISION, THE ATTENDING ONCOLOGY SURGEON NOTED A SPARK AND FLAME FROM THE BOVIE TIP WHILE INSIDE THE PATIENT'S ABDOMEN. THE PENCIL/TIP WAS IMMEDIATELY PUT INTO WATER, AND THE PROCEDURE CONTINUED WITH ALL NEW EQUIPMENT. THE ORIGINAL BOVIE PENCIL APPEARED TO HAVE AN ASH-LIKE APPEARANCE, AND THE COATING WAS NO LONGER PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524054 ↗
• MalfunctionJun 5, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING SPINE AND CRANIOTOMY, THE INSULATION ON BLADE SCRAPED OFF. NO ADDITIONAL MEDICAL INTERVENTION PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468520 ↗
• MalfunctionOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BELOW THE KNEE AMPUTATION, THE TEAM WAS USING THE CAUTERY TO OBTAIN HEMOSTASIS AS PER USUAL. THERE WAS A NON-MEDTRONIC GAUZE SPONGE AT THE WOUND BUT NOT WHERE THEY WERE CAUTERIZING (MAYBE 3CM AWAY) AND THEY NOTICED THAT IT TURNED COLOR AND THEN A SMALL FLAME APPEARED. THE SPONGE WAS IMMEDIATELY REMOVED FROM THE FIELD. THERE WAS NO OBVIOUS FLAMMABLE SUBSTANCE ON THE FIELD, THE PREP WAS DONE AT THE BEGINNING OF THE CASE, AND THE PATIENT WAS INTUBATED, SO THERE WAS NO OXYGEN SOURCE ON THE FIELD. THERE WAS NO FIRE ON THE FIELD, WOUND, AND DRAPES AND THERE WAS NO SOOT OR CHAR. THE BOVIE PEN, GROUNDING PAD, AND MACHINE WERE ALL REMOVED FROM THE CASE. THE SPONGE WAS SECURED AS WELL. THEY WERE ABLE TO COMPLETE THE PROCEDURE SAFELY. THERE WAS NO PATIENT/STAFF INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024593 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A BREAST AUGMENTATION, A NEW BOVIE CAUSED A 1ST DEGREE BURN ON THE RIGHT PERI AREOLA OF THE PATIENT, THE SKIN BUBBLED AND WAS BURNED AFTER CONTACT WITH THE DEVICE. THE AREA OF BURN WAS EXCISED. THERE WAS NO ADDITIONAL MEDICATIONS GIVEN.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 17024601 ↗
• MalfunctionJun 24, 2022Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP WAS LOOSE CAUSING IT TO CONDUCT HEAT AND BURN THE PATIENT¿S SKIN.

  Patient problems: Burn(s)

  MAUDE report 14806646 ↗
• MalfunctionNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BREAST AUGMENTATION, THE DOCTOR USED THE PENCIL CAUTERY ON THE FIRST BREAST AND THEN WENT ON THE SECOND BREAST. THE DEVICE HAD OBVIOUS BREAK IN THE INSULATION ON THE LONG BOVIE TIP. THE PATIENT HAD A SECOND DEGREE BURN BELOW INFRAMAMMARY INCISION DURING CAUTERY DISSECTION. THE BURN WAS TREATED WITH ANTIBIOTIC OINTMENT. THERE WAS A MINIMAL DELAY IN THE PROCEDURE. JUST TO EXAMINE AREA AND OPEN NEW CAUTERY EXTENSION. THE CAUTERY COMES STERILE WITHIN THE CUSTOM PACK.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 12843343 ↗
• MalfunctionNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DOCTOR USED THE DEVICE ON THE FIRST BREAST AND THEN WENT ON THE SECOND BREAST. IT BURNED THE PATIENT. THIS CAUTERY COMES STERILE WITHIN THE CUSTOM PACK.

  Patient problems: Burn(s)

  MAUDE report 12778985 ↗
• MalfunctionOct 4, 2020Self-Activation or Keying; Connection Problem; Self-Activation or Keying; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS NON-RESPONSIVE WHEN PLUGGED INTO THE GENERATOR. MEDTRONIC TROUBLESHOOTING OF THE RETURNED DEVICE FOUND THAT WHEN THE PENCIL WAS SELF ACTIVATING IN THE CUT MODE WHEN PLUGGED INTO THE GENERATOR AND 40 KOHM BOX.

  Patient problems: No Information

  MAUDE report 10624508 ↗
• MalfunctionAug 20, 2020Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICES' PUSH BUTTON FIRED UP ONCE THE DEVICE WAS PLUGGED INTO THE CAUTERY MACHINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433896 ↗
• MalfunctionAug 20, 2020Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICES' PUSH BUTTON FIRED UP ONCE THE DEVICE WAS PLUGGED INTO THE CAUTERY MACHINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433885 ↗
• MalfunctionOct 10, 2019Fire; Fire

  ACCORDING TO THE REPORTER, THE PENCIL WAS CAUGHT ON FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9174584 ↗
• MalfunctionApr 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE DEVICE CAUSED 3 MINOR BURNS TO THE PATIENT DESPITE BEING GROUNDED. THE GENERATOR ASSOCIATED WITH THE DEVICE WAS TESTED AND PASSED ALL QUALITY CHECKS.

  Patient problems: Burn(s)

  MAUDE report 8472991 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, THE DEVICE TURNED ITSELF "ON" WITH THE BUTTON ON THE OFF" POSITION RESULTING IN BURNS ON THE PATIENT'S BODY. THERE WAS TWO 3RD DEGREE BURNS AND 3 2ND DEGREE BURNS. THE 3RD DEGREE BURN ON RIGHT MONS PUBIS AND LEFT LEG. 2ND DEGREE BILATERAL LABIA MINORA INFERIOR TO THE CLITORIS. THE SURGEON REMOVED BURNT SKIN IN TWO 3RD DEGREE BURNS AND PLACED 3 SUTURES. THEY ALSO APPLIED SILVER SULFADIAZINE CREAM. THE PROCEDURE WAS DELAYED FOR 5-10 MINUTES. THE PATIENT IS CURRENTLY HEALING WELL.

  Patient problems: Full thickness (Third Degree) Burn; No Code Available; Partial thickness (Second Degree) Burn

  MAUDE report 8429176 ↗
• MalfunctionOct 19, 2018Fire; Fire

  ACCORDING TO THE REPORTER, THE PENCIL CAUGHT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985037 ↗
• MalfunctionSep 7, 2017Detachment Of Device Component; Peeled/Delaminated; Detachment Of Device Component; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE CAUTERY PENCIL WAS DEFECTIVE. THE RUBBER LAYER HAS BEEN PEELED BACK WHICH IN TURN ALLOWS THIS CLEAR PLASTIC PIECE TO DISLODGE FROM THE BOVIE TIP AND BECOME A FOREIGN BODY. THE ISSUE OCCURRED DURING A SPINE CASE. THE PIECE FELL WITHIN THE WOUND AND WAS LOCATED BEFORE ANY PATIENT HARM OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INCIDENT DEVICE IS AN ELECTRODE. THE ELECTRODE IS NOT AVAILABLE FOR EVALUATION HOWEVER A PICTURE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850037 ↗