Neptune E-SEP 0703046000Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 07613327117189), received between Jun 12, 2018 and May 15, 2026 — classified as 14 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (29 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE ESEP SAFEAIR PENCIL ACTIVATED WITHOUT PRESSING ANY BUTTONS BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183877 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE AT THE USER FACILITY, THE ELECTROSURGICAL PENCIL BECAME VERY HOT AND CAUSED A BURN TO THE PATIENT¿S SKIN. IT WAS REPORTED THAT THE BURN WAS ASSESSED AS THIRD TO FOURTH DEGREE DUE TO THE DEPTH OF TISSUE INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EVENT REQUIRED MEDICAL INTERVENTION. AFFECTED SKIN AND UNDERLYING ADIPOSE TISSUE WERE REMOVED, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED, AND THE BURN MEASURED APPROXIMATELY 8.5 CM BY 2.5 CM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24688279 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE AT THE USER FACILITY, THE ELECTROSURGICAL PENCIL BECAME VERY HOT AND CAUSED A BURN TO THE PATIENT¿S SKIN. IT WAS REPORTED THAT THE BURN WAS ASSESSED AS THIRD TO FOURTH DEGREE DUE TO THE DEPTH OF TISSUE INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EVENT REQUIRED MEDICAL INTERVENTION. AFFECTED SKIN AND UNDERLYING ADIPOSE TISSUE WERE REMOVED, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED, AND THE BURN MEASURED APPROXIMATELY 8.5 CM BY 2.5 CM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24688255 ↗
• MalfunctionJan 28, 2026Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE SMOKE EVAC PENCIL ACTIVATED WITHOUT PRESSING ANY BUTTONS BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198730 ↗
• InjuryJan 16, 2026Unintended Power Up

  IT WAS REPORTED THAT, DURING USE AT THE USER FACILITY, THE USER DID NOT USE THE HOLSTER AND PLACED THE DEVICE ON THE PATIENT¿S LEG, CAUSING A THIRD-DEGREE BURN. IT WAS FURTHER REPORTED THAT THE PENCIL WAS NOT TURNED ON MANUALLY WHEN PLACED ON THE PATIENT¿S LEG. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY.

  Patient problems: Burn(s)

  MAUDE report 24094985 ↗
• MalfunctionDec 9, 2025Defective Device

  BOVIE WAS PLUGGED INTO MACHINE PROPERLY BUT DID NOT FUNCTION OUT OF PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756205 ↗
• MalfunctionDec 1, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23683773 ↗
• MalfunctionDec 1, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO ADDITIONAL INFORMATION PROVIDED, THE NON-STRYKER ELECTRODE WAS USED DURING THE SURGERY.

  Patient problems: Burn(s)

  MAUDE report 23679415 ↗
• MalfunctionNov 21, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618281 ↗
• InjuryNov 21, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT, DURING USE AT THE USER FACILITY, THE DEVICE UNINTENTIONALLY ACTIVATED, CAUSING A THIRD DEGREE BURN, THAT REQUIRED POST OPERATION DRESSING CHANGE ORDERS. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23616826 ↗
• InjurySep 18, 2025Fire; Fire

  IT WAS REPORTED THAT, DURING USE AT THE USER FACILITY, THE E-SEP PENCIL GOT CLOSE TO A PIECE OF HAIR WITH BETADINE AND THE HAIR CAUGHT ON FIRE, CAUSING A SECOND-DEGREE BURN TO THE PATIENT'S FOREHEAD AND EXTENDING ONTO THE FACE. IT WAS FURTHER REPORTED THAT THE BURNS REQUIRED ADDITIONAL TREATMENT IN ANOTHER HOSPITAL. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23084949 ↗
• MalfunctionSep 18, 2025Fire; Fire

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, A FLAME CAME OUT OF THE PENCIL WHICH CAUSED THE PLASTIC TO MELT. NO INFORMATION WAS PROVIDED REGARDING ANY ADVERSE CONSEQUENCES, MEDICAL INTERVENTION, OR SURGICAL DELAY. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084943 ↗
• MalfunctionSep 15, 2025Device Remains Activated; Device Remains Activated

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23050467 ↗
• MalfunctionAug 18, 2025Electrical /Electronic Property Problem; Mechanical Problem

  BOVIE SMOKE EVACUATOR WAS PLUGGED INTO BOVIE MACHINE TO BE USED DURING THE CASE BUT WHEN THE SURGEON WENT TO USE BOVIE IT DID NOT EMIT ELECTRICITY. BOVIE WAS REPLACED WITH A NEW ONE AND NEW BOVIE WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826762 ↗
• MalfunctionJun 24, 2025Output below Specifications; Output below Specifications

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321009 ↗
• MalfunctionJun 24, 2025Output below Specifications; Output below Specifications

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE COAG FUNCTION OR CUT FUNCTION ON THE E-SEP SAFEAIR PENCIL DID NOT WORK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321003 ↗
• MalfunctionJun 24, 2025Output below Specifications; Output below Specifications

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE COAG FUNCTION OR CUT FUNCTION ON THE E-SEP SAFEAIR PENCIL DID NOT WORK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320792 ↗
• MalfunctionJun 17, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BOVIE PENCIL REMAINED ACTIVATED DUE TO A STUCK BUTTON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYS, AND NO ADVERSE CONSEQUENCES OR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226374 ↗
• MalfunctionJun 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT UPON RECEIVING, THE DEVICE PACKAGING WAS FOUND TO BE DAMAGED/HAVING HOLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131245 ↗
• InjuryApr 24, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING THE C-SECTION AT THE USER FACILITY, THE COAGULATION ACTIVATION ALARM WENT OFF, AND IT WAS MISINTERPRETED AS AS A GROUND FAULT ALARM. THE USER CONTINUED USING THE ELECTROSURGICAL PENCIL, RESULTING IN BURNS ON BOTH OF THE BABY'S BUTTOCKS, WHICH REQUIRED TRANSFER TO ANOTHER HOSPITAL FOR TREATMENT IN A BURN UNIT. THIS REPORT IS RELATED TO MFG REPORT # 3015967359-2025-00938.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21899763 ↗
• InjuryApr 23, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING THE C-SECTION AT THE USER FACILITY, THE COAGULATION ACTIVATION ALARM WENT OFF, AND IT WAS MISINTERPRETED AS A GROUND FAULT ALARM. THE USER CONTINUED TO USE THE PENCIL AND AS A RESULT THE MOTHER HAD BURNS ON HER INNER THIGHS WHICH REQUIRED TREATMENT. NO INFORMATION WAS PROVIDED REGARDING THE SEVERITY OF THE BURN OR THE TYPE OF THE TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 21890058 ↗
• MalfunctionMar 26, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A HOT CAUTERY TIP ACCIDENTALLY TOUCHED THE PATIENT AND LEFT A BURN MARK. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A DELAY.

  Patient problems: Burn(s)

  MAUDE report 21699658 ↗
• MalfunctionMar 6, 2025Device Remains Activated; Device Remains Activated

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534946 ↗
• MalfunctionJan 2, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP PENCIL DID NOT WORK BUT THE CUT FUNCTION DID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056144 ↗
• MalfunctionJan 2, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP PENCIL DID NOT WORK BUT THE CUT FUNCTION DID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056141 ↗