IMAGE 1 TH111Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551358931), received between Oct 6, 2023 and May 22, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026No Display/Image

  IT WAS REPORTED THAT "WHEN THE CAMERA HEAD ARE NOT MOVED, THE DISPLAY DOES NOT APPEAR ON THE MONITOR.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262712 ↗
• MalfunctionFeb 10, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A COMPLETE SIGNAL LOSS (BLUE SCREEN) DURING AN ONGOING COELIOSCOPY PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306310 ↗
• MalfunctionDec 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT "THE SCREEN SUDDENLY DEFAULTED TO THE HOME SCREEN AS IF THE CAMERA HE'D HAD BEEN REMOVED. THIS HAPPENED SEVERAL TIMES DURING THE PROCEDURE, HOWEVER THE IMAGE WAS QUICKLY RESTORED THEREAFTER.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858114 ↗
• MalfunctionDec 10, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE ENDOSOPIC IMAGE WAS LOST DURING USE. STAFF WERE THEN REQUIRED TO RESOLVE THIS ISSUE BY PLUGGING ANOTHER UROLOGY PENDULUM CAMERA HEAD INTO THE STACK IN USE, WHICH THEN ALLOWED THE SURGERY TO PROCEED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770495 ↗
• MalfunctionDec 10, 2025Erratic or Intermittent Display; Signal Artifact/Noise; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE CAMERA HEAD TH111 WAS PURCHASED FOR A UROLOGY STACK. WHEN THE STACK IS USED WITH LASERS, CLINICAL STAFF HAVE REPORTED INTERFERENCE ON THE MONITOR. THE SCREEN WAS FLICKERING AND HAD ARTEFACTS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770464 ↗
• MalfunctionMay 12, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DEVICE DID NOT WORK WHEN THE CUSTOMER TRIED TO USE IT FOR THE FIRST TIME. THEY DOUBLE CHECKED IT AGAIN, AND STILL NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004084 ↗
• InjuryMay 2, 2025Erratic or Intermittent Display; No Display/Image; Image Display Error/Artifact; Erratic or Intermittent Display; No Display/Image; Image Display Error/Artifact

  IT WAS REPORTED THAT THE IMAGE IS DISTORTED ON SCREEN WHICH MAKES THE PICTURE DIFFICULT TO SEE. IT WAS FURTHERMORE STATED THAT THIS WAS NOTICE DURING A PATIENT PROCEDURE, BUT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-APR-2025. REGARDING THE REPORTED ERROR IT WAS STATED "NO IMAGE OUTPUT AND SCREEN DISPLAYED WITH MULTIPLE LINES FLICKERING WHEN THE CAMERA WAS USED ON THE PATIENT". FURTHERMORE, IT WAS CONFIRMED AGAIN THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT GOT DISCHARGED HOME SAFE, BUT IT WAS ALSO INDICATED THAT THE PROCEDURE WAS PROLONGED BETWEEN 30 AND 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952188 ↗
• InjuryMay 2, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE IS DISTORTED ON SCREEN WHICH MAKES THE PICTURE DIFFICULT TO SEE. IT WAS FURTHERMORE STATED THAT THIS WAS NOTICE DURING A PATIENT PROCEDURE, BUT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-APR-2025. REGARDING THE REPORTED ERROR IT WAS STATED "NO IMAGE OUTPUT AND SCREEN DISPLAYED WITH MULTIPLE LINES FLICKERING WHEN THE CAMERA WAS USED ON THE PATIENT". FURTHERMORE, IT WAS CONFIRMED AGAIN THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT GOT DISCHARGED HOME SAFE, BUT IT WAS ALSO INDICATED THAT THE PROCEDURE WAS PROLONGED BETWEEN 30 AND 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952186 ↗
• InjuryOct 6, 2023Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED THAT "MID SURGERY, WHEN USING THE CAMERA SYSTEM ALONGSIDE A DIATHERMY, THE STACK LOST THE PICTURE ON THE LARGE MONITOR DUE TO INTERFERENCE". FURTHERMORE: "ELONGATED AND INCOMPLETE PROCEDURE. POSSIBLE REQUIREMENT OF SECONDARY PROCEDURE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886677 ↗
• InjuryOct 6, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT "MID SURGERY, WHEN USING THE CAMERA SYSTEM ALONGSIDE A DIATHERMY, THE STACK LOST THE PICTURE ON THE LARGE MONITOR DUE TO INTERFERENCE". FURTHERMORE: "ELONGATED AND INCOMPLETE PROCEDURE. POSSIBLE REQUIREMENT OF SECONDARY PROCEDURE."

  Patient problems: Insufficient Information

  MAUDE report 17886673 ↗