Neptune E-SEP 0703047000Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 07613327117202), received between Jul 2, 2018 and Apr 15, 2026 — classified as 11 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (61 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Oct 4, 2024Open, Classified

   There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

   Z-0368-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 4, 2024Open, Classified

   There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

   Z-0365-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE USER FACILITY, THE ESEP PENCIL CAUGHT ON FIRE. IT WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885179 ↗
• MalfunctionMar 4, 2026Unintended Power Up

  IT WAS REPORTED THAT DURING INSPECTION THE ESEP PENCIL HAD FAULTY CONTINUITY. THERE WAS NO ASSOCIATED PROCEDURE; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512862 ↗
• MalfunctionFeb 9, 2026Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE USER FACILITY, THE ESEP PENCIL CAUGHT ON FIRE. IT WAS ALSO REPORTED THAT A NON STRYKER ELECTRODE WAS USED. NO INFORMATION WAS AVAILABLE IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY ADVERSE CONSEQUENCES OR SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24294009 ↗
• MalfunctionFeb 5, 2026Unintended Power Up; Fire

  DURING A PROCEDURE, IT WAS REPORTED THAT THE ESEP PENCIL ACTIVATED WITHOUT THE SURGEON PRESSING ANY BUTTONS, AND THE PENCIL CAUGHT ON FIRE. IT WAS FURTHER REPORTED THAT A NON STRYKER ELECTRODE WAS USED AND THE HOLSTER WAS NOT USED WHEN THE DEVICE GOT CAUGHT ON FIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY, AND NO ADVERSE CONSEQUENCES OR PATIENT INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269375 ↗
• MalfunctionDec 17, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829308 ↗
• MalfunctionNov 4, 2025Unintended Power Up; Unintended Power Up

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463660 ↗
• MalfunctionAug 19, 2025Fire; Fire

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843026 ↗
• MalfunctionJul 31, 2025Output below Specifications; Output below Specifications

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678044 ↗
• MalfunctionJul 31, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP SAFEAIR 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 22678040 ↗
• MalfunctionJul 31, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP SAFEAIR 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 22674945 ↗
• MalfunctionJul 30, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP SAFEAIR 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 22664431 ↗
• MalfunctionJul 28, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE GENERATOR ALARM WENT OFF AND IT WAS NOTED THAT THE E-SEP SAFEAIR PENCIL ACTIVATED WITHOUT PRESSING ANY BUTTONS AND COULD NOT BE TURNED OFF. 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 22630154 ↗
• MalfunctionJul 23, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAG FUNCTION ON THE E-SEP SAFEAIR 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 22577653 ↗
• MalfunctionMay 14, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUT FUNCTION OF THE BOVIE PENCIL REMAINED ACTIVATED EVEN AFTER THE SURGEON HAD SWITCHED IT OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY, AND NO ADVERSE CONSEQUENCES OR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019008 ↗
• MalfunctionApr 24, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING PREPARATION, PRIOR TO A PROCEDURE, THE BOVIE TRIGGERED AN ERROR ON THE GENERATOR, WHICH WAS NOT IMMEDIATELY NOTED. THE NURSE BELIEVED THE BOVIE MAY HAVE ACTIVATED ON ITS OWN. THE DEVICE WAS QUICKLY DISCONNECTED. 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 21899771 ↗
• InjuryMar 24, 2025Unintended Power Up; Unintended Power Up

  ACCORDING ADDITIONAL INFORMATION PROVIDED, THE E-SEP PENCIL WAS USED PARALLEL TO AND IN CLOSE PROXIMITY WITH TWO OTHER ELECTRICAL DEVICES. IT WAS FURTHER REPORTED THAT THE POWER SETTING WAS INCREASED FROM COAG 30/40, CUT 30 TO COAG 60¿80 DURING THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 21679250 ↗
• MalfunctionJan 6, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078691 ↗
• MalfunctionOct 25, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A CAUTERY TIP BURNED HOLES IN DRAPES. 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 SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532116 ↗
• MalfunctionOct 21, 2024Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A CAUTERY TIP BURNED HOLES IN DRAPES. 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 SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496355 ↗
• InjuryOct 18, 2024Improper or Incorrect Procedure or Method; Excessive Heating; Improper or Incorrect Procedure or Method; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, A BURN TO THE PATIENT WHILE USING SMOKE EVAC PENCIL. IT WAS FURTHER REPORTED THAT THE BURN REQUIRED MEDICAL INTERVENTION TO SUTURE THE BURN, AS IT WAS 1.5CM SKIN LACERATION. IT WAS ALSO REPORTED THAT THE EVENT WILL RESULT IN A SCAR TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY.

  Patient problems: Burn(s)

  MAUDE report 20480853 ↗
• MalfunctionOct 11, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE REMAINS ¿HOT¿ AFTER USE AND BURNS HOLES IN THE DRAPES. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427191 ↗
• InjuryOct 10, 2024Improper or Incorrect Procedure or Method; Excessive Heating; Improper or Incorrect Procedure or Method; Excessive Heating

  IT WAS REPORTED THAT DURING USE IN AN ANTERIOR CRUCIATE LIGAMENT(ACL) RECONSTRUCTION PROCEDURE AT THE USER FACILITY, THE DEVICE WHEN PLACED ON THE DRAPES CAUSED A BURN TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE BURN REQUIRED MEDICAL INTERVENTION TO CUT AWAY CHARRED TISSUE AND SUTURE THE WOUND. IT WAS ALSO REPORTED THAT THE EVENT WILL RESULT IN A SCAR TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 20417718 ↗
• MalfunctionJul 2, 2024Melted; Melted

  IT WAS REPORTED THAT DURING A PROCEDURE THE CHAR WAS BUILDING UP ON THE TIP AND IT LOOKS AS IF IT MELTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655102 ↗
• MalfunctionJun 7, 2024Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGING FOR THE E-SEP PENCIL. THERE WAS NO PATIENT IMPACT, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484396 ↗
• MalfunctionMay 10, 2024Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE, THE E-SEP PENCIL PLUGGED IN AND IMMEDIATELY STARTED 'ACTIVATING' CUT ON CAUTERY MACHINE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288052 ↗