IMAGE1 CONNECT TC200USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551356586), received between Feb 9, 2018 and Jul 30, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666436 ↗
• MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00796.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012524 ↗
• MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00792

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012523 ↗
• MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00794.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012522 ↗
• MalfunctionFeb 9, 2018Device Operates Differently Than Expected

  ALLEGEDLY, DURING SET UP FOR A LAPAROSCOPY PROCEDURE, THE LIGHT SOURCE, WITH A LIGHT CABLE CONNECTED, WAS IN STAND-BY MODE AND THE LIGHT CABLE WAS NOT CONNECTED TO A SCOPE. WHEN THE CAMERA HEAD WAS CONNECTED TO THE TS200US CAMERA CONTROL UNIT (CCU) , THE LIGHT SOURCE AUTOMATICALLY WENT TO PREVIOUS SETTING OF 100% LIGHT INTENSITY AND, BECAUSE THE LIGHT CABLE WAS NOT CONNECTED TO A SCOPE AND IT WAS IN CONTACT WITH THE PATIENT'S DRAPE, THE DRAPE WAS BURNED. THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261844 ↗
• MalfunctionFeb 9, 2018Computer Software Problem; Programming Issue; Computer Software Problem; Programming Issue

  ALLEGEDLY, DURING SET UP FOR A HYSTEROSCOPY PROCEDURE, THE LIGHT SOURCE, WITH A LIGHT CABLE CONNECTED, WAS IN STAND-BY MODE AND THE LIGHT CABLE WAS NOT CONNECTED TO A SCOPE. WHEN THE CAMERA HEAD WAS CONNECTED TO THE TS200US CAMERA CONTROL UNIT (CCU) , THE LIGHT SOURCE AUTOMATICALLY WENT TO PREVIOUS SETTING OF 100% LIGHT INTENSITY AND, BECAUSE THE LIGHT CABLE WAS NOT CONNECTED TO A SCOPE AND IT WAS IN CONTACT WITH THE PATIENT'S DRAPE, THE DRAPE WAS BURNED. THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261842 ↗