n.a. 11101HDRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04048551416389), received between Mar 4, 2025 and Sep 25, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905111 ↗
• MalfunctionSep 25, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904974 ↗
• MalfunctionSep 9, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697618 ↗
• MalfunctionSep 9, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694579 ↗
• MalfunctionAug 26, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458755 ↗
• MalfunctionFeb 10, 2026Circuit Failure; Optical Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT SHOWS IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306344 ↗
• MalfunctionJan 17, 2026Device Reprocessing Problem; No Display/Image

  IT WAS REPORTED "NO IMAGE, NO LIGHT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24105497 ↗
• MalfunctionJan 5, 2026Circuit Failure; No Display/Image

  IT WAS REPORTED "DOES NOT SHOW IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968595 ↗
• MalfunctionSep 18, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem

  THE FOLLOWING WAS REPORTED: LIGHT BUT NO IMAGE. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD PARTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085973 ↗
• MalfunctionSep 4, 2025No Display/Image; No Display/Image

  ACCORDING TO THE INFORMATION RECEIVED, THERE IS NO IMAGE ON THE TELEPACK. THERE IS AN AIR LEAK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974157 ↗
• MalfunctionAug 28, 2025No Display/Image; Use of Device Problem; No Display/Image; Use of Device Problem

  IT WAS REPORTED THAT THE IMAGE WENT BLACK AND THERE WAS NO LIGHT OUTPUT FROM THE SCOPE DURING PROCEDURE. THE SCOPE WAS WITHDRAWN, AFTER WHICH A NEW SCOPE HAD TO BE INTRODUCED. THE SURGICAL PROLONGATION WAS LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912238 ↗
• MalfunctionJul 8, 2025No Display/Image; Output Problem; No Display/Image; Output Problem

  IT WAS REPORTED THAT "UNABLE TO TEST/DUE TO NO IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; Lethargy

  MAUDE report 22439564 ↗
• MalfunctionJul 8, 2025Electrical /Electronic Property Problem; Optical Obstruction; Electrical /Electronic Property Problem; Optical Obstruction

  IT WAS REPORTED THAT PICTURE WENT PURPLE AND SWITCH ITSELF OFF MID CONSULTATION. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439550 ↗
• MalfunctionJun 26, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED WARRANTY REPAIR, INSTRUMENT IS NOT WORKING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338776 ↗
• MalfunctionApr 2, 2025Circuit Failure; No Display/Image; Circuit Failure; No Display/Image

  IT WAS REPORTED THAT THE VIDEO RHINO-LARYNGOSCOPE HAS "NO IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759193 ↗
• MalfunctionMar 4, 2025No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT "NO IMAGE, NEW UNIT, NO HUMIDITY INSIDE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515604 ↗