IMAGE 1Recalls & reported problems across all models
Karl Storz GmbH & Co. KG · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 3 models of IMAGE 1 by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2021 and Sep 24, 2026 — classified as 6 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (14 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 problems
Device problems
- Erratic or Intermittent Display14
- No Display/Image14
- No Apparent Adverse Event9
- Display or Visual Feedback Problem6
- Poor Quality Image5
- Optical Distortion4
- Corroded2
- Image Display Error/Artifact2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information7
IMAGE 1 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMAGE 1 TH100Endoscopic video imaging system/component, gastroenterology-urology20 reports
- IMAGE 1 TH110Endoscopic video imaging system/component, gastroenterology-urology19 reports
- IMAGE 1 TH111Endoscopic video imaging system/component, gastroenterology-urology10 reports
Recent IMAGE 1 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891932 ↗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 ↗MalfunctionAug 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50119387 ↗MalfunctionJul 17, 2026Circuit Failure; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861747 ↗MalfunctionJul 9, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769179 ↗MalfunctionJul 9, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769160 ↗MalfunctionJun 16, 2026Loose or Intermittent Connection; Optical Distortion
THE FOLLOWING WAS REPORTED: "THE INCIDENT OCCURRED ON MAY 6, DURING WHICH SCREEN DISTORTION WAS OBSERVED IN THE ENDOSCOPIC CAMERA SYSTEM DURING SURGERY. NO HARM WAS CAUSED TO THE PATIENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522565 ↗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 ↗MalfunctionMay 8, 2026Erratic or Intermittent Display; Poor Quality Image
IT WAS REPORTED THAT "THERE IS NOISE IN THE IMAGE.". FURTHERMORE, IT WAS FOUND DURING INITIAL PRODUCT EVALUATION THAT THERE IS INTERMITTENT IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128620 ↗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 ↗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 ↗
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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