None 490108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874119839), received between Feb 23, 2023 and Feb 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionFeb 23, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE MAGNETIC SWIVEL CONNECTOR, WHICH ATTACHES TO THE ENDOTRACHEAL TUBE (ETT), BECAME DISCONNECTED (MULTIPLE TIMES) FROM THE DOCKING SPAR, THE PART OF THE ION SYSTEM CART THAT DOCKS TO THE ETT. THE SITE RISK MANAGER REPORTED THAT DURING THE DISCONNECTIONS, ANESTHETIC GAS BEGAN TO LEAK INTO THE ROOM FROM THE UPPER PORT , WHERE THE ROBOTIC INSTRUMENTS AND BRONCHOSCOPES ARE INTRODUCED. THE FINAL TIME IT DISCONNECTED, ¿THE SWIVEL CONNECTOR BEGAN VENTING THE GAS INTO THE ROOM (WITH NO GAS BEING RECEIVED BY THE PATIENT)¿. THE MINOR PROCEDURES TECHNICIAN (TECHNICIAN) HAD BEEN ASKED TO HOLD THE CONNECTOR IN PLACE, RESULTING IN THE TECHNICIAN INHALING THE GAS FOR A COMBINED TOTAL OF 8 (EIGHT) MINUTES OVER TIME. THE TECHNICIAN EXPERIENCED DIZZINESS AND REQUESTED THAT THE SWIVEL CONNECTOR BE EXCHANGED. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) SWITCHED OUT THE MAGNETIC SWIVEL CONNECTOR WHICH REQUIRED DISENGAGEMENT OF THE ANESTHETIC GAS, RESULTING IN CHANGING TO IV PROPOFOL FOR CONTINUED ANESTHESIA/SEDATION. AFTER THE SWIVEL CONNECTOR WAS REPLACED, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENCE. THE TECHNICIAN WAS THEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425442 ↗
• MalfunctionFeb 23, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE MAGNETIC SWIVEL CONNECTOR, WHICH ATTACHES TO THE ENDOTRACHEAL TUBE (ETT), BECAME DISCONNECTED (MULTIPLE TIMES) FROM THE DOCKING SPAR, THE PART OF THE ION SYSTEM CART THAT DOCKS TO THE ETT. THE SITE RISK MANAGER REPORTED THAT DURING THE DISCONNECTIONS, ANESTHETIC GAS BEGAN TO LEAK INTO THE ROOM FROM THE UPPER PORT , WHERE THE ROBOTIC INSTRUMENTS AND BRONCHOSCOPES ARE INTRODUCED. THE FINAL TIME IT DISCONNECTED, ¿THE SWIVEL CONNECTOR BEGAN VENTING THE GAS INTO THE ROOM (WITH NO GAS BEING RECEIVED BY THE PATIENT)¿. THE MINOR PROCEDURES TECHNICIAN (TECHNICIAN) HAD BEEN ASKED TO HOLD THE CONNECTOR IN PLACE, RESULTING IN THE TECHNICIAN INHALING THE GAS FOR A COMBINED TOTAL OF 8 (EIGHT) MINUTES OVER TIME. THE TECHNICIAN EXPERIENCED DIZZINESS AND REQUESTED THAT THE SWIVEL CONNECTOR BE EXCHANGED. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) SWITCHED OUT THE MAGNETIC SWIVEL CONNECTOR WHICH REQUIRED DISENGAGEMENT OF THE ANESTHETIC GAS, RESULTING IN CHANGING TO IV PROPOFOL FOR CONTINUED ANESTHESIA/SEDATION. AFTER THE SWIVEL CONNECTOR WAS REPLACED, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENCE. THE TECHNICIAN WAS THEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425437 ↗