IMAGE 1 TH100Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04048551333136), received between Aug 13, 2021 and Aug 28, 2026 — classified as 2 injuries, 18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Erratic or Intermittent Display

  Correction to the faulty product.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499305 ↗
• MalfunctionAug 25, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439098 ↗
• MalfunctionAug 6, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162790 ↗
• MalfunctionJul 9, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769179 ↗
• MalfunctionApr 8, 2026Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT "THE CAMERA HEAD, SERIAL NUMBER (B)(6), BECAME FOGGED DURING THE FIRST PROCEDURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823060 ↗
• MalfunctionMar 30, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: THE SCREEN IMAGING IS BLURRED; NORMAL FUNCTION IS RESTORED AFTER REPLACING THE CAMERA. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719777 ↗
• MalfunctionMar 6, 2026Poor Quality Image

  IT WAS REPORTED THAT "DURING TESTING WITH THE ENDOSCOPE CAMERA SYSTEM: AFTER A PERIOD OF USE, THE CAMERA IMAGE BECAME FOGGY, RESULTING IN UNCLEAR VIEW AND UNUSABLE CONDITION. THE CAMERA IMAGE WAS NORMAL, BUT THE APERTURE COULD NOT BE ADJUSTED, AFFECTING INTRAOPERATIVE OBSERVATION. THE DEVICE HAS BEEN TAKEN OUT OF SERVICE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537121 ↗
• MalfunctionDec 30, 2025No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  IT WAS REPORTED THAT CAMERA WAS RECOGNIZED BY THE PROCESSOR, BUT THERE WAS NO IMAGE AND INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923568 ↗
• InjuryDec 29, 2025Sparking; Sparking

  IT WAS REPORTED THAT THE SURGEON FELT A 'SPARK' OR A SHOCK WHEN USING THIS CAMERA AND THEY JUMPED. A STAFF MEMBER WITH THE SURGEON CLAIMS THERE WERE NO OTHER ELECTRICAL DEVICES, AND THE SURGEON WAS WEARING GLOVES. WE RECKON IT WAS SOMETHING ELSE OR THE SURGEON THEMSELVES THAT HAD THE ISSUE, AND NOT THE DEVICE. COULD BE STATIC. WE COMPLETED AN EST WITH APPLIED PARTS (ON THE CAMERA'S BARE METAL PART), AND IT PASSED". SINCE THE SURGEON FELT A 'SPARK' OR A SHOCK WHEN USING THIS CAMERA, THIS CASE IS REPORTABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908240 ↗
• MalfunctionDec 22, 2025Unexpected Shutdown; Unexpected Shutdown

  ACCORDING TO THE INFORMATION RECEIVED, THE CAMERA IS DEFECTIVE AND STOPS WORKING DURING OPERATION. IT WAS TESTED ON TWO DIFFERENT PROCESSORS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865648 ↗
• MalfunctionDec 8, 2025Optical Distortion; Optical Distortion

  THE FOLLOWING WAS REPORTED: "CLOUDY IMAGE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23746951 ↗
• MalfunctionOct 15, 2025Output Problem; Output Problem

  IT WAS REPORTED "BLACK SCREEN NO IMAGE DURING CASE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302399 ↗
• MalfunctionSep 18, 2025Signal Artifact/Noise; No Display/Image; Signal Artifact/Noise; No Display/Image

  IT WAS REPORTED THAT THE IMAGE FLICKERS OVER THE SCREEN AND LINES SOMETIMES APPEAR WHEN YOU WIGGLE THE CAMERA CABLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089753 ↗
• MalfunctionAug 7, 2025Fracture; Optical Problem; Fracture; Optical Problem

  IT WAS REPORTED THAT THE "EQUIPMENT EXPERIENCES INTERFERENCE WHEN THE HEAD IS MOVED DURING SURGERY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739010 ↗
• MalfunctionMay 23, 2025Optical Problem; Optical Problem

  THE FOLLOWING WAS REPORTED: "BLURRY IMAGES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081473 ↗
• MalfunctionMay 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE IMAGE SHUT OFF MID PROCEDURE (DATE, TYPE AND ADDITIONAL DETAILS NOT PROVIDED). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005947 ↗
• MalfunctionMar 5, 2025Erratic or Intermittent Display; Mechanical Problem; Poor Quality Image; Erratic or Intermittent Display; Mechanical Problem; Poor Quality Image

  IT WAS REPORTED THAT "DURING THE PROCEDURE, THE IMAGE JUMPS, AND IT IS NOT CLEAR. A DIFFERENT TH100 WAS USED TO COMPLETE THE PROCEDURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21528677 ↗
• MalfunctionFeb 10, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE IMAGE BECOME BLACK AFTER 15 MINUTES. THE DEVICE NEEDS TO BE RESTARTED TO SOLVE THE ISSUE. AFTER RESTART, THERE IS A COLOR CASE, OR THE VIDEO PROCESSOR REPORTS AN INCOMPATIBLE CAMERA. NO HARM TO THE PATIENT, USER, OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354038 ↗
• MalfunctionJan 13, 2023Display or Visual Feedback Problem; Moisture or Humidity Problem; Display or Visual Feedback Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE IMAGE CUT OUT DURING CASE NO PATIENT INJURY. PROCEDURE WAS COMPLETED USING A BACK-UP CAMERA. THE SURGERY WAS DELAYED APPROXIMENTLY 5 TO 6 MINUTES. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158999 ↗
• InjuryAug 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): DURING SURGERY, THE IMAGE OF THE CAMERA WAS INTERMITTENT. THE CUSTOMER SWITCHED TO OPEN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12320991 ↗