n.a. 11575ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551006252), received between Sep 18, 2025 and Sep 30, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Optical Distortion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954076 ↗
• MalfunctionAug 27, 2026Display or Visual Feedback Problem

  The following was reported: "no image." No negative impact in state of health reported.

  Patient problems: Insufficient Information

  MAUDE report 50480488 ↗
• InjuryJun 15, 2026Optical Problem

  THE FOLLOWING WAS REPORTED: "A 54-YEAR-OLD PATIENT WAS ADMITTED FOR A PAROTID SIALENDOSCOPY. AFTER INDUCTION OF ANESTHESIA, DURING THE EQUIPMENT CHECK, THE SIALENDOSCOPE WAS FOUND TO BE NON-FUNCTIONAL: THERE WAS NO VISIBILITY ON THE VIDEO COLUMN SCREEN (NO IMAGE), AND THE OPTICAL FIBERS APPEARED TO BE BROKEN. THE PATIENT WAS AWAKENED, AND THE REPROCESSING PROCEDURE FOR THE SECOND SIALENDOSCOPE WAS INITIATED FOR URGENT STERILIZATION, IN PREPARATION FOR A REINTERVENTION LATER THE SAME AFTERNOON.

  Patient problems: Insufficient Information

  MAUDE report 25513148 ↗
• MalfunctionDec 29, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCOPE HAD NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915488 ↗
• MalfunctionNov 26, 2025Break; No Display/Image; Break; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659241 ↗
• MalfunctionNov 10, 2025No Display/Image; Break; No Display/Image

  IT WAS REPORTED: THE SCOPE STOPPED PROVIDING AN IMAGE DURING THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514636 ↗
• MalfunctionSep 18, 2025Fracture; Optical Problem; Fracture; Optical Problem

  IT WAS REPORTED THAT LENS IS FOGGY IN THE EYE PIECE. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089758 ↗