Hunsaker 7080100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00681490156431), received between Dec 5, 2016 and Nov 27, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING A LASER SURGERY TO THE LARYNX PROCEDURE, THE CATHETER WAS REPOSITIONED INTRA-OPERATIVELY BUT THE PROCEDURE CONTINUED UNEVENTFULLY. THE PATIENT WAS ANAESTHETISED USING A JETTING CATHETER AND JET VENTILATOR. THE PATIENT WAS EXTUBATED BUT THE JETTING CATHETER HAD INADVERTENTLY BEEN DAMAGED CAUSING THE DISTAL PART OF THE CATHETER TO BE LEFT IN THE AIRWAY. THIS WAS NOTICED BY THE CONSULTANT ANAESTHETIST AND APPROPRIATE MEASURES WERE UNDERTAKEN IMMEDIATELY. THE CONSULTANT SURGEON REMOVED THE RETAINED PART AND PATIENT SAFETY WAS ENSURED. THERE WAS NO AIRWAY ISSUE OR CONCERN. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8106874 ↗
• MalfunctionMar 23, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT "THE TUBE WAS INSPECTED AND NO FAULT WAS OBSERVED. IT WAS THEN INSERTED INTO THE PATIENT, BUT THE INTUBATION FAILED, SO THE TUBE WAS REMOVED. ON REMOVAL THEY OBSERVED THAT THE GREEN BASKET AT THE END OF THE TUBE WAS NOT FULLY ATTACHED ANYMORE. NO PARTS WERE LEFT IN THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6428713 ↗
• InjuryDec 5, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: THE DEVICE APPEARED NORMAL PRIOR TO INTUBATION. THE ANCHOR PIECE DETACHED WHILE REMOVING THE TUBE; FORCEPS WERE USED TO RETRIEVE THE DETACHED PIECE. THE PATIENT WAS UNDERGOING A MICROLARYNGOSCOPY POSTERIOR GLOTTOPLASTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6145858 ↗