Neptune 0702001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613154522309), received between Jun 4, 2018 and Oct 5, 2020 — classified as 1 death, 39 malfunctions.

The most frequently reported specific device problem is “Filtration Problem” (14 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE'S SMOKE EVACUATOR FAILED. 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 10630611 ↗
• MalfunctionJun 22, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A PROCEDURE, THE DEVICE'S POWER CORD BURNED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER USE OF THE DEVICE. NO SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178370 ↗
• MalfunctionFeb 18, 2020Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE'S SMOKE EVACUATOR FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722268 ↗
• MalfunctionFeb 18, 2020Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE'S SMOKE EVACUATOR FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722100 ↗
• MalfunctionDec 13, 2019Sparking; Sparking

  IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE'S POWER CORD WAS SPARKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9469852 ↗
• MalfunctionJul 30, 2019Circuit Failure; Circuit Failure

  IT WAS REPORTED BY THE CUSTOMER THAT DURING SET UP FOR A PROCEDURE, THE DEVICE'S PLUG SPARKED. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841776 ↗
• MalfunctionJul 22, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING SETUP FOR A PROCEDURE AT THE USER FACILITY THE NEPTUNE ROVER SHOCKED AN EMPLOYEE. THE EMPLOYEE WAS NOT HARMED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE, WITH NO SURGICAL DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES TO THE PATIENT OR EMPLOYEE.

  Patient problems: Shock

  MAUDE report 8813010 ↗
• MalfunctionJul 16, 2019Circuit Failure; Circuit Failure

  IT WAS REPORTED BY THE CUSTOMER THAT DURING SET UP FOR A PROCEDURE, THE DEVICE'S PLUG WAS FOUND CHARRED. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793741 ↗
• MalfunctionJul 1, 2019Increase in Suction; Increase in Suction

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEPTUNE INCREASED IN SUCTION WITHOUT BEING PROMPTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8749350 ↗
• MalfunctionMay 9, 2019Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING DURING SET UP. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596339 ↗
• MalfunctionApr 12, 2019Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE SMOKE EVACUATOR STOPPED FUNCTIONING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511373 ↗
• MalfunctionApr 9, 2019Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE'S SMOKE EVACUATOR FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496179 ↗
• MalfunctionApr 1, 2019Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE'S SMOKE EVACUATOR FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470425 ↗
• MalfunctionMar 8, 2019Smoking; Smoking

  IT WAS REPORTED THAT THE DEVICE WAS SMOKING FROM THE POWER CORD DURING SET UP BEFORE A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405522 ↗
• MalfunctionFeb 22, 2019Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE SMOKE EVACUATOR STOPPED FUNCTIONING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362688 ↗
• MalfunctionFeb 1, 2019Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING AND SMOKING DURING SET UP. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297898 ↗
• MalfunctionJan 2, 2019Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING.  NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208289 ↗
• DeathDec 20, 2018Off-Label Use; Off-Label Use

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN OPEN ABDOMEN PROCEDURE, A PATIENT EXPERIENCED CARDIOPULMONARY ARREST. PER THE CUSTOMER, AT THE TIME, THE NEPTUNE WAS USED AS A "WOUND VAC" (VACUUM ASSISTED CLOSURE) IN THE PROCEDURE, THE PATIENT NO LONGER SHOWED VITAL SIGNS. THE CUSTOMER FURTHER REPORTED THAT A CUSTOMER EMPLOYEE ATTEMPTED TO USE THE NEPTUNE DEVICE TO CREATE A "WOUND VAC" TO THE AREA WHERE BLEEDING WAS PROFUSE. THE PATIENT WAS REPORTED TO HAVE DIED DURING THE PROCEDURE. PER THE ORIGINAL REPORTER FROM THE CUSTOMER, THE NEPTUNE IN NO WAY CAUSED OR CONTRIBUTED TO THE DEMISE OF THE PATIENT. WHILE IT WAS REPORTED THAT THE NEPTUNE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S CONDITION PER THE ORIGINAL REPORTER, USING THE NEPTUNE IN CONJUNCTION WITH CLOSED WOUND DRAINS IS A CONTRAINDICATION OR USAGE AND COULD RESULT IN A SERIOUS INJURY.

  Patient problems: Death

  MAUDE report 8185131 ↗
• MalfunctionDec 20, 2018Fire; Fire

  IT WAS REPORTED THAT WHILE DOCKING THE ROVER AT THE USER FACILITY THE DEVICE LEAKED AND HAD AN INTERNAL ELECTRICAL FIRE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING DOCKING OF THE ROVER AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184509 ↗
• MalfunctionDec 7, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A MAMMOPLASTY PROCEDURE AT THE USER FACILITY THE DEVICE WAS USED INCORRECTLY AS A SOURCE OF SUCTION IN THE CHEST AREA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141835 ↗
• MalfunctionNov 13, 2018Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064453 ↗
• MalfunctionNov 7, 2018Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING AND SMOKING FROM THE POWER CORD DURING TESTING BEFORE A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047786 ↗
• MalfunctionNov 5, 2018Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING DURING TESTING BEFORE A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039411 ↗
• MalfunctionOct 29, 2018Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE NEPTUNE 2 ROVER ULTRA'S SMOKE EVACUATOR FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015900 ↗
• MalfunctionOct 23, 2018Sparking; Sparking

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS SPARKING DURING TESTING BEFORE A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994964 ↗