IMAGE 1 S TH120Recalls & reported problems

Karl Storz GmbH & Co. KG · IMAGE1 S 4U · Class 2

Quick summary

This Karl Storz IMAGE1 S TH120 endoscopic video imaging system is used in gastroenterology and urology procedures. Most of its 30 reports describe picture problems during surgery — blank, flickering, blurry or dark images, and times when the camera head or its cable was thought to have come unplugged, in one case leading surgeons to convert a laparoscopic procedure to an open one. Three reports describe injuries, and none describe deaths. No recall names this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 27
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04048551370506), received between Mar 9, 2021 and Aug 31, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (9 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Display/Image9
Erratic or Intermittent Display5
Display or Visual Feedback Problem4
Adverse Event Without Identified Device or Use Problem3
Insufficient Device Problem Information3
No Apparent Adverse Event3
Optical Problem3
Defective Component2

Patient problems

No Clinical Signs, Symptoms or Conditions23
Insufficient Information2
Superficial (First Degree) Burn2

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 31, 2026Erratic or Intermittent Display
Connection problems with the screen were reported, it's possible that it's cord. The screen flickers. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524657 ↗
MalfunctionJul 16, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841952 ↗
InjuryJun 19, 2026No Display/Image
THE FOLLOWING WAS REPORTED: "CAMERA HEAD WAS FAULTY, OR CAMERA UNPLUGGED. THE PROCEDURE WAS CONVERTED FROM LAP TO OPEN. THE CASE WAS COMPLETED. UPON FURTHER INVESTIGATION IT IS UNCLEAR WHETHER THE CAMERA HEAD WAS FAULTY, OR IF IT WAS JUST THE CAMERA BOX THAT WAS UNPLUGGED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564188 ↗
MalfunctionApr 28, 2026No Display/Image
IT WAS REPORTED THAT INTERMITTENT IMAGE PROBLEMS OCCURED DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020359 ↗
MalfunctionApr 2, 2026No Display/Image
ACCORDING TO THE INFORMATION RECEIVED, NO IMAGE WAS OBSERVED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24771927 ↗
MalfunctionJan 27, 2026Optical Problem
IT WAS REPORTED THAT THE IMAGE DISPLAYS BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193748 ↗
MalfunctionJan 16, 2026Display or Visual Feedback Problem
THE FOLLOWING WAS REPORTED: "CHECKED AND FOUND NO IMAGE DISPLAY WHEN CONNECTED TO CCU CONNECTOR CONTACT POINTS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24104876 ↗
MalfunctionNov 26, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE DEVICE HAS A BLURRY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660628 ↗
MalfunctionNov 12, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT, PRIOR TO THE PROCEDURE, THE IMAGE FLICKERED WHEN THE CAMERA HEAD WAS CONNECTED TO THE CAMERA BOX. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538503 ↗
InjurySep 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT "WHEN THE CAMERA HEAD IS CONNECTED TO THE CAMERA BOX, THE IMAGE FLICKERS, AND THE SURGEON CANNOT SEE THE PATIENT'S ANATOMY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE PATIENT WAS MOVED ANESTHETIZED, TO ANOTHER OR FOR THE PROCEDURE TO BE COMPLETED. THEY PULLED A NEW CAMERA HEAD FOR THE CASE TO MOVE ON IN A DIFFERENT OR. THERE WAS A DELAY OF AT LEAST ONE HOUR. CROSS REFERENCE MDR: 2027009-2025-01622.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23087257 ↗
InjurySep 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT "WHEN THE CAMERA HEAD IS CONNECTED TO THE CAMERA BOX, THE IMAGE FLICKERS, AND THE SURGEON CANNOT SEE THE PATIENT'S ANATOMY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE PATIENT WAS MOVED ANESTHETIZED, TO ANOTHER OR FOR THE PROCEDURE TO BE COMPLETED. THEY PULLED A NEW CAMERA HEAD FOR THE CASE TO MOVE ON IN A DIFFERENT OR. THERE WAS A DELAY OF AT LEAST ONE HOUR. CROSS REFERENCE MDR: 2027009-2025-01623.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23087134 ↗
MalfunctionAug 21, 2025Optical Problem; Optical Problem
THE FOLLOWING WAS REPORTED: CAMERA WILL NOT PRODUCE ANY IMAGE WHEN CONNECTED TO 4U LINK, REMAINS ON MAIN MENU SCREEN. DOCTOR HAD TO SWITCH CAMERAS AT THE BEGINNING OF CYSTO CASE, CAUSED NO HARM JUST A DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22864939 ↗
MalfunctionAug 15, 2025No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE CAMERA HEAD CABLE HAD A LOOSE CONNECTION, WHICH CAUSED THE SCREEN TO REPEATEDLY TURN BLACK. THE SURGICAL PROLONGATION TOOK LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819822 ↗
MalfunctionJul 24, 2025Display or Visual Feedback Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE CAMERA PRESENTED A SHAKING IMAGE AND SOMETIME A BLACK SCREEN. THE SHAKING IS NOT PERMANENT. IT OCCURED FEW TIMES THE SOUND OF THE UNITS ARE VERY ACUTE AND IS SUGGESTING A FAN PROBLEM. THIS SITUATION OCCURED DURING USE AND DURING A TEST IN OUR TECHNICAL DEPARTMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR PROLONGATION OF SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589469 ↗
MalfunctionJul 24, 2025Display or Visual Feedback Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE CAMERA PRESENTED A SHAKING IMAGE AND SOMETIME A BLACK SCREEN. THE SHAKING IS NOT PERMANENT. IT OCCURED FEW TIMES THE SOUND OF THE UNITS ARE VERY ACUTE AND IS SUGGESTING A FAN PROBLEM. THIS SITUATION OCCURED DURING USE AND DURING A TEST IN OUR TECHNICAL DEPARTMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR PROLONGATION OF SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589313 ↗
MalfunctionJul 21, 2025No Display/Image; Material Split, Cut or Torn; No Display/Image; Material Split, Cut or Torn
ACCORDING TO THE INFORMATION RECEIVED, AFTER ONLY 4 USES (AFTER RETURNED FROM SERVICE) THE SAME PROBLEM OCCURRED. THE CAMERA DOES NOT GIVE IMAGE WHEN CONNECTED. NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22558065 ↗
MalfunctionJul 10, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT INTERMITTENT IMAGES OCCURRED DURING THE PROCEDURE, BUT THEY WERE ABLE TO COMPLETE THE PROCEDURE BY USING A BACKUP CAMERA HEAD. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22472959 ↗
MalfunctionJun 24, 2025Optical Problem; Optical Problem
ACCORDING TO THE INFORMATION RECEIVED, NOT GIVING ANY PICTURE AFTER SHORT TIME. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323685 ↗
MalfunctionMay 31, 2025Output Problem; Output Problem
IT WAS REPORTED THAT DURING THE USE, THE DEVICE TURNS OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22120745 ↗
MalfunctionMay 2, 2025No Display/Image; Defective Component; No Display/Image; Defective Component
IT WAS REPORTED THAT THERE IS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954442 ↗
MalfunctionMay 2, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING A VAAFT PROCEDURE, THE IMAGE ON THE MONITOR WAS LOST FOR A BRIEF SECOND, TWICE IN SHORT SUCCESSION. THE SURGEON SAID IT WAS WHILE USING DIATHERMY. [[?]] PICTURE FLICKERED WHEN DIATHERMY MACHINE WAS BEING USED THEN WENT OFF WHILE USING DIATHERMY. FURTHERMORE, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952233 ↗
MalfunctionMay 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING A PROCEDURE (TYPE NOT PROVIDED), THE IMAGE WENT BLACK AND THE WHITE BALANCE WAS INCOMPLETE. NO HARM TO PATIENT, USER OR THIRD OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH A DELAY OF 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942953 ↗
MalfunctionApr 28, 2025No Display/Image; Defective Component; No Display/Image; Defective Component
IT WAS REPORTED THAT THE "CAMERA HEAD WITH INTERMITTENT FAULT NOT DISPLAYING IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21923281 ↗
MalfunctionFeb 6, 2025No Display/Image; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; No Display/Image; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT LOSS OF IMAGE ON SURGICAL MONITOR 2 LOTS OR1AIR HAPPENED AT THE SAME TIME IN THE SAME THEATRE ON THE SAME PATIENT. THERE WAS A TEMPORARY BLANK SCREEN FOR APPROX. 15 SECONDS WHILST SURGERY WAS IN PROGRESS THERE WAS A FAULTY MONITOR - FURTHER INVESTIGATION NEEDED AS THIS MAY ALSO BE AS A RESULT OF AN ISSUE WITH THE TC201EN, OR TH120, OR OR1AIR (WD300 / AVM). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00147. 9610617-2025-00149.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329695 ↗
MalfunctionNov 22, 2024Break; Intermittent Communication Failure; Break; Intermittent Communication Failure
IT WAS REPORTED THAT DURING THE PROCEDURE THE PICTURE OF THE CAMERA IS GONE. AFTER A SHORT PERIOD THE PICTURE IS BACK. NO HARM TO PATIENT, USER OR THIRD REPORTED. NO NEGATIVE CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763152 ↗

Device details

UDI-DI	`04048551370506`
Brand	IMAGE 1 S
Model	TH120
Company	Karl Storz GmbH & Co. KG
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 19, 2024

Device type (GMDN): Endoscope video camera

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.