Nebulae I 7-650-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00817183020189), received between Jul 12, 2019 and Apr 24, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Gas Output Problem; Increase in Pressure

  ON 03/27/2026 NORTHGATE TECHNOLOGIES INC. WAS MADE AWARE OF AN EVENT OCCURRING IN JAPAN. THE FOLLOWING INFORMATION WAS PROVIDED TO NTI UNDER COMPLAINT NUMBER (B)(4). NON-CONFORMANCE ID #: 76-03-28 IS THE COMPLAINT SAMPLE AVAILABLE? YES CONTAMINATED: NO HAS THE SURGEON/HOSPITAL REQUESTED TO RECEIVE A COMPLAINT CLOSURE LETTER? YES TIMING OF DETECTION: DURING USE REJECTED QTY: 1 DESCRIPTION: IMMEDIATELY AFTER STARTING TO USE THE UNIT, THE PATIENT'S STOMACH BECAME BLOATED DUE TO EXCESSIVE PRESSURE, AND SUBCUTANEOUS EMPHYSEMA DEVELOPED. ACTION: TURNED OFF THE UNIT, REBOOTED IT, AND REUSED IT AGAIN. HEALTH PROBLEM: YES IF YES, DETAILED INFO.: THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA, BUT RECOVERED QUICKLY AND DID NOT REQUIRE EXTENSION OF HOSPITALIZATION.

  Patient problems: Abdominal Distention

  MAUDE report 24988054 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON JANUARY 2ND, 2026 NTI RECEIVED A COMPLAINT WHERE THE CUSTOMER REPORTED, "AFTER SETTING THE CAMERA PORT, CONNECTING THE INSUFFLATION TUBE TO THE PORT, AND STARTING INSUFFLATION, THE PATIENT'S BLOOD PRESSURE DROPPED TO 30 MMHG APPROXIMATELY ONE MINUTE LATER. THE PATIENT'S FACE ALSO TURNED RED, AND A PNEUMOTHORAX DEVELOPED, STOPPING THE SURGERY. (THIS OCCURRED BEFORE THE TAP CONNECTION, SMOKE EVACUATION, AND CAMERA INSERTION.) THE NEXT DAY, OUR TECHNICIAN CHECKED THE DEVICE'S OPERATION AND FOUND IT TO BE FUNCTIONING NORMALLY."

  Patient problems: Pneumothorax

  MAUDE report 24205218 ↗
• MalfunctionMay 2, 2025Increase in Pressure; Increase in Pressure

  ON (B)(6) 2025 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, "DURING USE, THE NEBULAE I UNIT CONTINUES TO INSUFFLATE OVER 30 MMHG FOR SECONDS WITH NO ALARM. ACTION: USED THE UNIT UNTIL THE END OF THE SURGERY."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21947441 ↗
• MalfunctionMar 28, 2025Increase in Pressure; Increase in Pressure

  ON 02/27/2025 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, " DURING USE, OVERPRESSURIZATION OCCURRED, CAUSING THE LID OF THE WRAP DISK TO FLY OFF, AND THE PATIENT'S STOMACH TO SWELL. THE PATIENT'S VITAL SIGNS ALSO TEMPORARILY DROPPED BUT RECOVERED AND NO ADDITIONAL TREATMENT WAS REQUIRED."

  Patient problems: Unspecified Heart Problem; Unspecified Respiratory Problem

  MAUDE report 21725019 ↗
• MalfunctionNov 18, 2021Increase in Pressure; Increase in Pressure

  ON (B)(6) 2021 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, "RIGHT AFTER THE FIRST INSUFFLATION (NO OTHER TROCAR WAS INSERTED YET), THE UNIT INSUFFLATED TOO MUCH AND THE PATIENT'S BODY WAS GETTING PUMPED UP (PNEUMO WAS SOLID AS A ROCK).- THERE IS NO HEALTH INJURY.- MESENTERY SURGERY.- NOT REPEATABLE AT (B)(4) ACTION: REBOOTED-UP THE UNIT AND RESTARTED THE SURGERY AT 5LPM, 10MMHG. THERE WAS NO PROBLEM AFTER THAT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840684 ↗
• MalfunctionMar 19, 2021Increase in Pressure; Increase in Pressure

  ON (B)(6) 2021 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT WITH AN INSUFFLATOR FROM DISTRIBUTOR (B)(4) LOCATED IN (B)(4), "...THIS UNIT COULD NOT MAINTAIN A STABLE PNEUMO AND A PATIENT'S STOMACH WAS TOO BLOATED...." FURTHER INFORMATION WAS RECEIVED AFTER REQUESTS FROM NORTHGATE TECHNOLOGIES IN WHICH THE FOLLOWING INFORMATION WAS PROVIDED: 02/20/2021 "WAS THERE ANY ADVERSE EFFECT TO THE PATIENT? HOW WAS THE PROCEDURE COMPLETED? - PNEUMOHYPODERMA. ANY OTHER AFFECTS WERE NOT CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEBULAE UNIT." AND 2/22/2021 "THIS UNIT COULD NOT MAINTAIN A STABLE PNEUMO. THERE WAS NO ADVERSE EVENT." THEREFORE THIS COMPLAINT / EVENT IS BEING SUBMITTED AS A DEVICE MALFUNCTION REPORT AS THERE WAS NO ADVERSE EVENT.

  Patient problems: Skin Disorders

  MAUDE report 11532332 ↗
• MalfunctionJul 30, 2020Increase in Pressure; Increase in Pressure

  ON 06/10/20, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED ISSUE WITH AN INSUFFLATOR FROM DISTRIBUTOR (B)(4) IN (B)(4) WHERE IT WAS ALLEGED, "DURING USE, INSUFFLATION BY NEBULAE I DIDN'T STOP AND THE PATIENT'S ABDOMEN SWELLED. NEBULAE I WAS SET AT PRESSURE 10MMHG AND 25LPM WITH A SMOKE EVACUATOR. PHYSICIAN IMMEDIATELY VENTED GAS FROM A PORT AND USED ANOTHER UNIT AFTER THAT. THERE WAS NO ADVERSE EVENT. AFTER THAT, OUR ENGINEER SERVICED AND DID THE REPEATABILITY TEST. BUT NOTHING ABNORMAL WAS FOUND ON THE UNIT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348038 ↗
• MalfunctionFeb 5, 2020Increase in Pressure; Increase in Pressure

  ON (B)(6) 2020, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED ISSUE WITH AN INSUFFLATOR FROM DISTRIBUTOR (B)(4) IN (B)(4) WHERE IT WAS ALLEGED, "DURING A REGULAR INSPECTION IN (B)(4), OUR TECH CHECKED THE UNIT AT VARIOUS SETTINGS AND FOUND OVER INSUFFLATION AT A SETTING. THERE IS NO HEALTH INJURY. AND IT OFTEN SHOWS TAP INDICATOR SYMBOL WITHOUT CONNECTING TAP TUBING. THIS SEEMS THE CAUSE OF MISS MONITORING PRESSURE AND OVER INSUFFLATION" FURTHER INFORMATION PROVIDED BY THE DISTRIBUTOR WHICH INDICATED THAT THIS DEVICE IS NOT ASSOCIATED WITH ANY ALLEGED MALFUNCTION BY THE CUSTOMER NOR WAS THERE ANY PATIENT INJURY OR DEATH ASSOCIATED WITH THE USE OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9673841 ↗
• MalfunctionJan 10, 2020Increase in Pressure; Increase in Pressure

  ON 12/12/19 NTI WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT "DESCRIPTION OF THE INCIDENT: PATIENT HAD MANY LAPAROSCOPIC SURGERY IN THE PAST, THEREFORE THERE WERE A LOT OF ADHESION THE PNEUMO. THE INITIAL INSUFFLATION WAS PERFORMED BY USING A 11 MM TROCAR TO ACHIEVE 15 MMHG AT 25 LPM OF FLOW. THE SALES REP WAS INDICATING THAT THE INSUFFLATOR'S PRESSURE READING WAS "RANDOM" AND NOT STEADILY INCREASING LIKE ALL OTHER LAPAROSCOPY. DURING INITIAL INSUFFLATION, ASSISTING SURGEON NOTICED THAT THE PNEUMO WAS ROCK HARD. AT THIS TIME, THE SALES REP LOWERED THE FLOW TO 5 LPM AND THE SURGEON INSERTED ANOTHER TROCAR (ASSUMING 5 MM) TO REMOVE ADHESION SURROUNDING THE PRIMARY TROCAR (11 MM). THE PNEUMO STABILIZED TO 15 MMHG OF PRESSURE AND SURGERY WAS COMPLETED WITHOUT ANY FURTHER INCIDENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578467 ↗
• MalfunctionAug 23, 2019Increase in Pressure; Increase in Pressure

  ON (B)(6) 2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED ISSUE WITH AN INSUFFLATOR FROM DISTRIBUTOR (B)(4) IN (B)(6) WHERE IT WAS ALLEGED, "DURING A LAPAROSCOPIC PROCEDURE, OUR CUSTOMER FOUND THAT INSUFFLATION IS UNSTABLE AND THE SIGN OF "RESTRICTION" WAS DISPLAYED ON NEBULAE I. AND THEN, THE PATIENT'S ABDOMEN WAS SUDDENLY BULGING TOO MUCH, AND THE UNIT DISPLAYED 50MMHG PRESSURE." FURTHER DETAILS: THE PROCEDURE WAS FOR OVER 10 HOURS. THE DEVICE WAS USED WITH NO TROUBLE FOR THE FIRST 6 HOURS. IN THE LATTER PART OF THE PROCEDURE, THE LEAK WAS FOUND DUE TO MAYBE A LOOSE TROCAR, AND THE FLOW RATE WAS ABOUT 20L/MIN. ABOUT 2 HOURS AFTER THAT, INSUFFLATION COULDN'T STOP. EVEN THOUGH THE PATIENT'S ABDOMEN WAS BULGING TOO MUCH, INSUFFLATION KEPT DOING. DURING THAT, THE DEVICE DISPLAYED THE PRESSURE WILD UPS AND DOWNS (2MMHG TO 20MMHG) WAS REPEATED AND GOT TOO HOT. THERE WERE NO HEALTH PROBLEMS NOTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8927088 ↗
• InjuryAug 16, 2019Increase in Pressure; Increase in Pressure

  ON (B)(6) 2019, NORTHGATE TECHNOLOGIES LOGGED A COMPLAINT OF AN ISSUE WITH AN INSUFFLATOR WHICH REPORTED THE FOLLOWING, "THE NEBULAE I SYSTEM OVER-INSUFFLATED. AT THE END OF THE CASE [THE SURGEON WAS] PULLING OUT SOME TROCARS. ONE OF THE TROCAR HAS THE TAP SENSING TUBING SET CONNECTED. AT THAT TIME, THE INSUFFLATOR RECORDED A PRESSURE THAT IS GREATER THAN 15 MMHG. THE FLOW WAS SET TO 50 LPM. ." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 INDICATING, "THE PROCEDURE WENT FINE UNTIL THE END WHEN THE INSUFFLATOR CONTINUED TO PUMP HIGH PRESSURE INTO THE ABDOMEN WHEN OTHER CONNECTIONS WERE REMOVED. THIS AFFECTED THE CARDIAC OUTPUT OF THE PATIENT AND ANESTHESIA HAD TO MEDICATE THE PATIENT. FORTUNATELY, PATIENT IS DOING FINE. ADDITIONALLY, [THE SURGEON] WAS CONCERNED THAT IT COULD AFFECT KIDNEY FUNCTIONS. [THE REP] BELIEVE[S] THE SYSTEM WAS NOT TURNED OFF AND CAUSED THIS. [THE SURGEON] FELT THAT THIS IS A PATIENT SAFETY ISSUE..."

  Patient problems: Low Cardiac Output

  MAUDE report 8901085 ↗
• MalfunctionJul 18, 2019Increase in Pressure; Increase in Pressure

  ON 6/21/19, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN INSUFFLATOR FROM DISTRIBUTOR AMCO IN (B)(4) WHERE IT WAS ALLEGED, "DURING USE, OUR CUSTOMER FOUND THE PATIENT'S ABDOMEN WAS BULGING TOO MUCH AND FELT DANGEROUS. NEBULAE I WAS SET AS PRESSURE 10MMHG BUT DISPLAYED OVER 20MMHG." "PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY NOT USING SURGICAL SMOKE EVACUATOR" "AFTER THAT, OUR ENGINEER DID THE REPEATABILITY TEST AND FOUND THAT WHEN THERE IS A DIFFERENCE BETWEEN THE MEASURE OF TAP [TRUE ABDOMINAL PRESSURE] AND THE MAIN UNIT, ABDOMINAL AIR PRESSURE WILL BE SOMETIMES TOO MUCH HIGH SUCH AS 50MMHG." IT WAS NOTED THAT THE "PHYSICIAN VENTED GAS." AND THERE WERE NO HEALTH PROBLEMS NOTED WITH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804822 ↗
• MalfunctionJul 12, 2019Increase in Pressure; Increase in Pressure

  ON 6/12/2019 NTI LOGGED A COMPLAINT WHERE IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY "OVER INSUFFLATED THE PNEUMO, WHILE THE NEBULAE I SYSTEM WAS INDICATING 15 MMHG... NEBULAE I SYSTEM WAS INSTRUCTED TO INSUFFLATE TO 15 MMHG AT 5 LPM OF FLOW IN VERRES NEEDLE MODE. DURING INSUFFLATION, THE DOCTOR WAS PLACING A UTERUS MANIPULATOR. AFTER THE MANIPULATOR WAS PLACED INSIDE THE PATIENT'S BODY, [THE DOCTOR] NOTICED THAT THE PNEUMO WAS SOLID AS A ROCK. [THE DOCTOR] THEN DISCONNECTED THE INSUFFLATION TUBING SET REDUCED THE PRESSURE BY DEFLATING A BIT." THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784979 ↗