n.a. 10101JARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551045268), received between Mar 3, 2021 and Mar 11, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT HOLDING PIN AND SPRING POPPED OUT OF THE PRISMATIC LIGHT DEFLECTOR WHILE BEING ATTACHED TO A LARYNGOSCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575754 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRINGING MECHANISM DROPPED INTO THE PATIENT'S AIRWAY DURING A PROCEDURE. THE CASE WAS DELAYED BY APPROXIMATELY 15MINS. THE DR. WAS ABLE TO GET THE SPRING OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212912 ↗
• InjuryJul 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A CASE ON APRIL-26-2024, THE SPRING CONNECTOR PIECE ON THE PRISMATIC LIGHT DEFLECTOR CAME APART AND THE 3 COMPONENTS HAD TO BE RETRIEVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. HOWEVER IT PROLONGED THE CASE AND THEY HAD TO DO AN X-RAY CHECK ON THE PATIENT TO CONFIRM THEY HAVE RETRIEVED ALL OF THE BROKEN PIECES FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785992 ↗
• InjuryMay 23, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2024, THE SPRING CONNECTOR PIECE ON THE PRISMATIC LIGHT DEFLECTOR CAME APART AND THE 3 COMPONENTS HAD TO BE RETRIEVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. HOWEVER IT PROLONGED THE CASE AND THEY HAD TO DO AN X-RAY CHECK ON THE PATIENT TO CONFIRM THEY HAVE RETRIEVED ALL OF THE BROKEN PIECES FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388153 ↗
• MalfunctionMar 3, 2021Material Separation; Material Separation

  PER THE FACILITY, AFTER A DIRECT LARYNGOSCOPY WITH BRONCHOSCOPY WHILE THE IN PACU THE PATIENT COUGHED UP 3 SMALL PIECES FROM THE LIGHT DEFLECTOR. PER THE OR NURSE NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11406332 ↗