IMAGE 1 TH110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04048551358924), received between Nov 26, 2024 and Sep 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891932 ↗
• MalfunctionAug 3, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50119387 ↗
• MalfunctionJul 17, 2026Circuit Failure; No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25861747 ↗
• MalfunctionJul 9, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769160 ↗
• MalfunctionJun 16, 2026Loose or Intermittent Connection; Optical Distortion

  THE FOLLOWING WAS REPORTED: "THE INCIDENT OCCURRED ON MAY 6, DURING WHICH SCREEN DISTORTION WAS OBSERVED IN THE ENDOSCOPIC CAMERA SYSTEM DURING SURGERY. NO HARM WAS CAUSED TO THE PATIENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522565 ↗
• MalfunctionMay 8, 2026Erratic or Intermittent Display; Poor Quality Image

  IT WAS REPORTED THAT "THERE IS NOISE IN THE IMAGE.". FURTHERMORE, IT WAS FOUND DURING INITIAL PRODUCT EVALUATION THAT THERE IS INTERMITTENT IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128620 ↗
• MalfunctionJan 21, 2026Erratic or Intermittent Display; No Apparent Adverse Event

  ACCORDING TO THE INFORMATION RECEIVED, INTERMITTENT SIGNAL INTERRUPTIONS OCCURRING. THE SIGNAL INTERRUPTIONS OCCURRED DURING A PRESENTATION OF THE DEVICE WITH THE STAFF AND NOT DURING A MEDICAL PROCEDURE, THERE WAS NO PATIENT INVOLVED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00094.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141592 ↗
• MalfunctionDec 22, 2025Corroded; Erratic or Intermittent Display; Corroded; Erratic or Intermittent Display

  IT WAS REPORTED THAT IMAGE FLICKERS WHEN CONNECT TO CCU. ACCORDING TO THE EVENT DESCRIPTION THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. SINCE THE RISK ANALYSIS IS BASED TO PATIENT, USER OR THIRD PARTY HARMS NO RISK-ID IS APPLICABLE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865589 ↗
• MalfunctionNov 26, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT WHEN CONNECTING CAMERA TO CAMERA BOX, NO IMAGE, NOT RECOGNIZING. TESTED WITH ANOTHER CAMERA THAT WORKED FINE. USED ONE TIME FOR A PRIOR PROCEDURE WITH NO ISSUES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660609 ↗
• MalfunctionNov 21, 2025Display or Visual Feedback Problem; Corroded; Display or Visual Feedback Problem

  ACCORDING TO THE INFORMATION RECEIVED, LOSS OF IMAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622493 ↗
• MalfunctionOct 24, 2025Output Problem; No Apparent Adverse Event; Output Problem; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383732 ↗
• MalfunctionAug 26, 2025Break; Optical Distortion; Break; Optical Distortion

  IT WAS REPORTED THAT THERE IS INTERMITTENT IMAGE TRANSMISSION. THERE IS NO INFORMATION IF THIS HAPPENED DURING SURGERY. 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 22895815 ↗
• MalfunctionJul 10, 2025No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE THE CAMERA DOESN'T SHOWS ANY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472379 ↗
• MalfunctionJul 2, 2025Loose or Intermittent Connection; No Apparent Adverse Event; Loose or Intermittent Connection; No Apparent Adverse Event

  IT WAS REPORTED THAT IN THE MIDDLE OF THE SURGERY, A MESSAGE APPEARED SAYING 'CAMERA HEAD NOT COMPATIBLE.' THE CABLE HAD A LOOSE CONNECTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22384389 ↗
• MalfunctionMay 7, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A FLICKERING IN IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979064 ↗
• MalfunctionFeb 25, 2025No Display/Image; Defective Component; No Display/Image; Defective Component

  IT WAS REPORTED THAT THERE WAS A LOOSE CONTACT AND IMAGE LOSS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. 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 21462361 ↗
• MalfunctionFeb 6, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CAMERA STARTED TO FLICKER DURING THE PROCEDURE. THE MEDICAL PROCEDURE WAS FINALIZED WITH THE USE OF THE FAULTY DEVICE. NO OTHER EQUIPMENT MALFUNCTIONS, BESIDES THE DESCRIBED PROBLEM WITH THE CAMERA, WERE OBSERVED. NO SURGICAL DELAY OR PROLONGATION OF SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR HARM.

  Patient problems: Insufficient Information

  MAUDE report 21327732 ↗
• MalfunctionNov 27, 2024Optical Obstruction; No Apparent Adverse Event; Optical Obstruction; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICES SHOW AN IMAGE DISTORTION WHEN USED WITH A LASER. THE CAMERA HEAD SATURATES THE WHITES AND LOSES FOCUS. NO HARM TO PATIENT, USER OR THIRD REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CROSS REFERENCE MDR: 9610617-2024-00472.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792599 ↗
• MalfunctionNov 26, 2024Optical Obstruction; No Apparent Adverse Event; Optical Obstruction; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICES SHOW AN IMAGE DISTORTION WHEN USED WITH A LASER. THE CAMERA HEAD SATURATES THE WHITES AND LOSES FOCUS. NO HARM TO PATIENT, USER OR THIRD REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CROSS REFERENCE MDR: 9610617-2024-00470.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787900 ↗