IMAGE1 H3-LINK TC300USRecalls & reported problems

Karl Storz GmbH & Co. KG · CCU,MODULAR,H3-LINK,US · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04048551356517), received between Feb 19, 2025 and Mar 17, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Optical 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Optical Problem4
Display or Visual Feedback Problem3
Erratic or Intermittent Display3
Output Problem2
Optical Distortion1

Patient problems

No Clinical Signs, Symptoms or Conditions12
Insufficient Information1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 17, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "WHEN THE CAMERA HEAD IS PLUGGED IN, THE IMAGE IS GRAINY/SNOWY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620128 ↗
MalfunctionFeb 19, 2026Output Problem
IT WAS REPORTED THAT CAMERA BOX TC300US MALFUNCTIONED DURING A CASE. NO IMAGE APPEARED. INSIDE OF THE CAMERA BOX APPEARED TO BE SLIGHTLY BURNED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390478 ↗
MalfunctionFeb 19, 2026Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, LOOSE PINS, IMAGE CUTTING OUT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390443 ↗
InjuryJan 28, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT "COMPLETE FAILURE CAUSING DELAYED SURGERY. COMPLETELY FAILED, NO DASHBOARD, NO VIDEO SIGNAL OUT OF ANY OUTPUT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2026. ACCORDING TO THE ADDITIONAL INFORMATION THE PROCEDURE WAS DELAYED BY ONE HOUR. CROSS REFERENCE MDRS: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00166, 2027009-2026-00167, 2027009-2026-00168.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202929 ↗
InjuryJan 28, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT "COMPLETE FAILURE CAUSING DELAYED SURGERY. COMPLETELY FAILED, NO DASHBOARD, NO VIDEO SIGNAL OUT OF ANY OUTPUT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00166, 2027009-2026-00167, 2027009-2026-00168.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202928 ↗
MalfunctionDec 23, 2025Optical Problem; Optical Problem
THE FOLLOWING WAS REPORTED: "WHEN THE CAMERA IS PLUGGED IN THE SCREEN GOES BLANK/BLACK". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23881907 ↗
MalfunctionOct 23, 2025Output Problem; Output Problem
IT WAS REPORTED THAT "WHEN INSERTING THE CAMERA, THE IMAGE GOES IN AND OUT. THE CAMERA PORT IS LOOSE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369080 ↗
MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00795.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012542 ↗
MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00793.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012527 ↗
MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING A SINUS DIAGNOSTIC ENDOSCOPY PROCEDURE (CASE DATE UNKNOWN), IMAGE ON THE MONITOR AND SMARTSCREEN FLICKERED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT IMPACT. CROSS REFERENCE MDR: 2027009-2025-00791.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012526 ↗
MalfunctionFeb 19, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE WAS NOT PROVIDED), DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407226 ↗
MalfunctionFeb 19, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE WAS NOT PROVIDED), DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407221 ↗
MalfunctionFeb 19, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE WAS NOT PROVIDED) ON (B)(6) 2025, DEVICE HAD INTERMITTING BLACKOUTS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP UNIT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407217 ↗

Device details

UDI-DI	`04048551356517`
Brand	IMAGE1 H3-LINK
Model	TC300US
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 12, 2025

Device type (GMDN): Endoscopic video image processing unit

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
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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