IMAGE 1 S TH104Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048551333969), received between Nov 17, 2022 and Jul 31, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105212 ↗
• MalfunctionApr 23, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT CAMERA HEAD IS DEFECTIVE OUT OF THE BOX AND FLICKERED DURING FIRST CASE USED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968250 ↗
• MalfunctionFeb 20, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT IMAGE FROM CAMERA WAS FLICKERING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408022 ↗
• MalfunctionDec 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT "THE CUSTOMER TRIED TO TURN ON THE UNIT THAT CAME FROM THE REPAIR AND GOT A BLACK SCREEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853578 ↗
• MalfunctionJul 10, 2025Optical Problem; Optical Problem

  ACCORDING TO THE EVENT DESCRIPTION WHEN TRYING TO USE CAMERA HEAD CAN'T SEE IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472984 ↗
• MalfunctionJun 5, 2025No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE HAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153264 ↗
• MalfunctionMar 4, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2025 (CASE TYPE WAS NOT PROVIDED), THE IMAGE TURNED BROWN. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP UNIT, WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521380 ↗
• MalfunctionOct 18, 2023Connection Problem; Connection Problem

  IT WAS REPORTED LOSS OF IMAGE DURING PROCEDURES. PROCEDURES COULD BE COMPLETED IN THREE CASES, EITHER USING A BACKUP UNIT OR THE SAME DEVICE AND NO HARM OCCURRED TO THE PATIENTS, USERS OR THIRD PARTIES. IN ONE CASE, NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE COULD BE OBTAINED AFTER MULTIPLE REQUEST ATTEMPTS. HOWEVER, IT IS UNLIKELY THAT THIS WOULD CAUSE PATIENT INJURY OR DEATH AS FACILITIES ROUTINELY HAVE BACK UP VIDEO EQUIPMENT THAT COULD BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962557 ↗
• MalfunctionOct 18, 2023Connection Problem; Connection Problem

  IT WAS REPORTED LOSS OF IMAGE DURING PROCEDURES. PROCEDURES COULD BE COMPLETED IN THREE CASES, EITHER USING A BACKUP UNIT OR THE SAME DEVICE AND NO HARM OCCURRED TO THE PATIENTS, USERS OR THIRD PARTIES. IN ONE CASE, NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE COULD BE OBTAINED AFTER MULTIPLE REQUEST ATTEMPTS. HOWEVER, IT IS UNLIKELY THAT THIS WOULD CAUSE PATIENT INJURY OR DEATH AS FACILITIES ROUTINELY HAVE BACK UP VIDEO EQUIPMENT THAT COULD BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962530 ↗
• MalfunctionOct 18, 2023Connection Problem; Connection Problem

  IT WAS REPORTED LOSS OF IMAGE DURING PROCEDURES. PROCEDURES COULD BE COMPLETED IN THREE CASES, EITHER USING A BACKUP UNIT OR THE SAME DEVICE AND NO HARM OCCURRED TO THE PATIENTS, USERS OR THIRD PARTIES. IN ONE CASE, NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE COULD BE OBTAINED AFTER MULTIPLE REQUEST ATTEMPTS. HOWEVER, IT IS UNLIKELY THAT THIS WOULD CAUSE PATIENT INJURY OR DEATH AS FACILITIES ROUTINELY HAVE BACK UP VIDEO EQUIPMENT THAT COULD BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962493 ↗
• MalfunctionOct 18, 2023Connection Problem; Connection Problem

  IT WAS REPORTED LOSS OF IMAGE DURING PROCEDURES. PROCEDURES COULD BE COMPLETED IN THREE CASES, EITHER USING A BACKUP UNIT OR THE SAME DEVICE AND NO HARM OCCURRED TO THE PATIENTS, USERS OR THIRD PARTIES. IN ONE CASE, NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE COULD BE OBTAINED AFTER MULTIPLE REQUEST ATTEMPTS. HOWEVER, IT IS UNLIKELY THAT THIS WOULD CAUSE PATIENT INJURY OR DEATH AS FACILITIES ROUTINELY HAVE BACK UP VIDEO EQUIPMENT THAT COULD BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962230 ↗
• MalfunctionNov 17, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT TH104 IMAGE1 S, H3-ZA CAMERA HEAD. CUSTOMER REPORTED THAT THE IMAGE WENT BLACK DURING A LAPAROSCOPIC SALPINGECTOMY PROCEDURE. CUSTOMER CONFIRMED THEY WERE ABLE TO COMPLETE THE CASE WITH ANOTHER CAMERA, AND THAT THERE WAS NO INJURY TO THE PATIENT. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814772 ↗