IMAGE 1 S TH102Recalls & reported problems
Karl Storz GmbH & Co. KG · IMAGE1 S H3-Z FI · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551333150), received between Sep 3, 2024 and Sep 16, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (3 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
Most reported problems
Device problems
- Poor Quality Image3
- Device-Device Incompatibility2
- Display or Visual Feedback Problem1
- Moisture or Humidity Problem1
- Shielding Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, 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 ↗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 ↗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 ↗InjuryJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SYSTEM REPORTS INCOMPATIBLE CAMERA HEAD. THE PATIENT WAS ALREADY SEDATED AND THE SURGERY HAD TO BE CANCELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103857 ↗InjuryJan 8, 2025Device-Device Incompatibility; Moisture or Humidity Problem; Device-Device Incompatibility; Moisture or Humidity Problem
IT WAS REPORTED THAT THE SYSTEM REPORTS INCOMPATIBLE CAMERA HEAD. THE PATIENT WAS ALREADY SEDATED AND THE SURGERY HAD TO BE CANCELED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103698 ↗MalfunctionSep 3, 2024Display or Visual Feedback Problem; Shielding Failure; Display or Visual Feedback Problem; Shielding Failure
IT WAS REPORTED THAT THE SCREENS ALL FLICKERED AND WENT BLACK DURING USE WHICH CAUSED A DELAY OF UNDER 15MINS. THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. NO HARM TO PATIENT, USER OR THIRD OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126898 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.