Neptune 2 0702020001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154733224), received between Mar 12, 2018 and Mar 12, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2018Suction Problem; Suction Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A GENERAL SURGERY PROCEDURE WITH DR. (B)(6) THE NEPTUNE EXHIBITED SUCTION LOWER THAN EXPECTED OR DESIRED. THE CUSTOMER FEELS IT'S PROBABLY AN ISSUE WITH MANIFOLD, COMMENTING THAT LOTS OF CHIPS (BONE) MIGHT HAVE CLOGGED THE MANIFOLD BASKET. THE CUSTOMER REPORTED THE DEVICE WAS BEING USED FOR FLUID COLLECTION. THE CUSTOMER COMMENTED THAT AS PART OF THEIR WORKFLOW, ROVERS CAN CROSS OVER FROM GENERAL CASES TO NEURO CASES. A MANIFOLD CLOGGING COULD LEAD TO INADEQUATE VISIBILITY TO THE SURGICAL FIELD DURING A HEMORRHAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO KNOWN IMPACT OR ADVERSE CONSEQUENCES TO THE PATIENT THAT WERE REPORTED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330089 ↗
• MalfunctionMar 12, 2018Suction Problem; Suction Problem

  IT WAS REPORTED BY A CIRCULATING NURSE AT THE USER FACILITY THAT A MANIFOLD WAS LIKELY TO HAVE CLOGGED CAUSING LOSS OF SUCTION DURING A PELVIC SARCOMA PROCEDURE. THE CUSTOMER INDICATED THAT TO HER KNOWLEDGE, ONLY BLOOD WAS BEING EXTRACTED, NO OTHER MATERIAL. IT WAS REPORTED THAT DURING THE CASE THE SURGEON WAS USING ABOUT 1 LITER OF BLOOD PER MINUTE, WITH A FINAL ESTIMATED BLOOD LOSS WAS 18L. THE NEPTUNE DEVICE THAT THE MANIFOLD WORKS IN CONJUNCTION WITH ALMOST COMPLETELY STOPPED PROVIDING SUCTION AT ONE POINT DURING THE PROCEDURE WHEN THE ABDOMEN WAS FILLING UP WITH BLOOD. THE CUSTOMER TRIED REMOVING AND REPLACING THE MANIFOLD SEVERAL TIMES AS THEY FELT IS WAS FILING UP. THE CUSTOMER WAS USING ONLY THE 20L CANISTER WITH 2 SUCTION LINES COMING FROM THE TOP 2 MANIFOLD PORTS, BOTH GOING TO THE FIELD. THE INITIAL SUCTION SETTING WAS "MEDIUM," WHEN THE SURGEON SIGNALED TO CIRCULATING NURSE THAT THE DEVICE WAS CLOGGING SHE TURNED IT UP TO "HIGH" BUT THE CLOGGING PERSISTED. THE CUSTOMER CONTINUED TRYING TO REMOVE AND REINSERT THE MANIFOLD WHICH WOULD WORK FOR A SHORT TIME AS THE SUCTION WOULD GET BETTER FOR A WHILE, BUT WOULD EVENTUALLY GET WORSE AGAIN. THE PROCEDURE WAS COMPLETED SUCCES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330042 ↗