IMAGE 1 SRecalls & reported problems across all models
Karl Storz GmbH & Co. KG · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 4 models of IMAGE 1 S by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Sep 16, 2026 — classified as 5 injuries, 41 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported IMAGE 1 S problems
Device problems
- No Display/Image11
- Erratic or Intermittent Display8
- Display or Visual Feedback Problem6
- Poor Quality Image6
- Connection Problem4
- No Apparent Adverse Event4
- Optical Problem4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information3
- Superficial (First Degree) Burn2
- No Known Impact Or Consequence To Patient1
IMAGE 1 S models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMAGE 1 S TH120Endoscopic video imaging system/component, gastroenterology-urology27 reports
- IMAGE 1 S TH104Endoscopic video imaging system/component, gastroenterology-urology12 reports
- IMAGE 1 S TH102Confocal optical imaging6 reports
- IMAGE 1 S TH116Endoscopic video imaging system/component, gastroenterology-urology1 report
Recent IMAGE 1 S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Poor Quality Image
It was reported that there was a pixilated haze ring around the edge of the viewing area. The issue could not be solved by changing the lens, but by changing the camera. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789752 ↗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 31, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105212 ↗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 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 ↗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 ↗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 ↗MalfunctionJan 28, 2026Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD A BLURRED VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201755 ↗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 ↗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 ↗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 21, 2025Poor Quality Image; Poor Quality Image
THE FOLLOWING WAS REPORTED: "SCRATCHY IMAGE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23622533 ↗
Other Karl Storz GmbH & Co. KG products
All Karl Storz GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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