Shiley 125239Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884522008792), received between Jan 10, 2018 and Sep 18, 2023 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN THE BRONCHO CATHETER TUBE WAS REPOSITIONED IN A LUNG TRANSPLANT PROCEDURE, AN HOUR FROM THE INITIAL SET-UP OF THE IOT PROBE. THE SINGLE-USE FIBERSCOPE HAS BLOCKED IN THE PROBE AND ITS DISTAL END BROKE INSIDE THE PROBE, CAUSING DESATURATION OF THE PATIENT TO 50%, BECAUSE THE DISTAL END OF THE FIBERSCOPE OBSTRUCTED THE PROBE MAKING THE VENTILATION OF THE PATIENT VERY DIFFICULT.

  Patient problems: Foreign Body In Patient; Low Oxygen Saturation

  MAUDE report 17764936 ↗
• MalfunctionJul 28, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WOULD NOT INFLATE OR DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239020 ↗
• InjuryJan 12, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, A PACKAGING ISSUE OCCURRED, IT WAS STATED THAT A COMPONENT WAS INCORRECT. THE CUSTOMER REPORTED THAT THE TUBE DISCONNECTED AND DESATURATION (SPO2=10%) OCCURRED WITHOUT THE POSSIBILITY TO USE MECHANICAL VENTILATION, RIGHT LUNG EXCLUSION, WHICH REQUIRED URGENT RETURN OF DECUBITUS DORSAL EXTUBATION AND THE NEW INTUBATION WITH A CONVENTIONAL TUBE.

  Patient problems: Extubate

  MAUDE report 7188024 ↗
• MalfunctionJan 10, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, "USE OF THIS NEW DOUBLE LIGHT TUBE EQUIPMENT FOR SURGERIES WHERE SELECTIVE INTUBATION IS ESSENTIAL; THIS TUBE HAS AN ERGOT TOO RIGID, WHICH IS TRAUMATIC." IT WAS REPORTED THAT THE Y CONNECTOR DISCONNECTED TWICE AND THERE WERE DIFFICULTIES TO ACCESS TO THE HEAD OF THE PATIENT DURING ROBOT SURGERY. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS, NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7180205 ↗