n.a. TC304USRecalls & reported problems
Karl Storz GmbH & Co. KG · IMAGE1 S 4U-LINK · Class 2
Quick summary
This Karl Storz IMAGE1 S 4U-Link imaging unit connects cameras for endoscopic viewing. Recent reports mostly describe loss of image with blue or black screens, flickering or cutting out when moved, sometimes with no signal to the camera. Of 23 reports that name its identifier, 4 mention injuries and no deaths were reported. No recalls name this device, with 21 reports in the last 12 months compared with 1 in the prior 12 months.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04048551418123), received between Mar 9, 2021 and Aug 17, 2026 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (5 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
- Display or Visual Feedback Problem5
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information4
- No Display/Image4
- Erratic or Intermittent Display3
- Detachment of Device or Device Component2
- Image Display Error/Artifact2
- Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Image Display Error/Artifact
It was reported that "Out-of-box: The 4U link was consistently dropping the image or cutting to a blue screen." No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280106 ↗MalfunctionJul 31, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105213 ↗MalfunctionApr 28, 2026No Display/Image
IT WAS REPORTED THAT THEY PLUGGED IN THE CAMERA HEAD AT THE BEGINNING OF THE PROCEDURE AND GOT A DARK BLUE SCREEN. THEY TRIED ANOTHER CAMERA HEAD ON THE SAME BOX AND SAME ISSUE OCCURRED. THEY TRIED THAT SAME CAMERA ON THE SPARE TOWER AND THAT WORKED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020299 ↗MalfunctionApr 2, 2026Image Display Error/Artifact
IT WAS REPORTED THAT THERE WAS NO SIGNAL. NOT COMMUNICATING WITH THE TC304US. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2026-00638.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24771926 ↗MalfunctionMar 26, 2026Output Problem
REPORTED ISSUE: "INCOMPATIBLE HEAD". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24706454 ↗MalfunctionFeb 19, 2026Output Problem
IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY BLANKING OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390479 ↗MalfunctionFeb 19, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT "WHEN THE CAMERA IS MOVED WHILE PLUGGED IN, THE SIGNAL CUTS OUT. EVEN IF THE MOVEMENT IS MINOR, THE IMAGE STILL CUTS OUT. INCONSISTENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390466 ↗MalfunctionFeb 19, 2026Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, UNABLE TO PULL UP A SIGNAL, NOT READING, BLACK SCREEN. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390455 ↗MalfunctionFeb 19, 2026Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, UNITS ARE NOT DISPLAYING AN IMAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390448 ↗MalfunctionFeb 19, 2026Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, UNITS ARE NOT DISPLAYING AN IMAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390445 ↗InjuryJan 28, 2026No Display/Image
IT WAS REPORTED THAT WILL NOT PRODUCE ANY IMAGE OR DASHBOARD. THE ISSUE CAUSED A DELAY OF THE PROCEDURE. THE PROLONGATION WAS LONGER THAN 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203158 ↗InjuryJan 28, 2026No Display/Image
IT WAS REPORTED THAT WILL NOT PRODUCE ANY IMAGE OR DASHBOARD. THE ISSUE CAUSED A DELAY OF THE PROCEDURE. THE PROLONGATION WAS LONGER THAN 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203156 ↗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, 2027009-2026-00165, 2027009-2026-00167, 2027009-2026-00168.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202932 ↗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 24202930 ↗MalfunctionJan 21, 2026Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A DROPPING THE SIGNAL INTERMITTENTLY. FAILED DURING THE CASE NO PATIENT INJURED. THEY SWAPPED TC304US AND THEY WERE ABLE TO FINISH THE CASE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24133919 ↗MalfunctionJan 8, 2026Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, PRONGS ARE BROKEN. NO INJURY TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005303 ↗MalfunctionJan 8, 2026Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, METAL BRACKET IS LOOSE/NOT HOLDING SCOPE. PROCEDURE DELAY AROUND 30 MINUTES. NO INJURY TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005302 ↗MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02404. 2027009-2025-02405.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874044 ↗MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02401 AND 2027009-2025-02402.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874042 ↗MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT "THE SYSTEM FROZE UP COMPLETELY DURING A CASE YESTERDAY, IN WHICH THEY HAD TO REBOOT THE SYSTEM". IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 2027009-2025-02398. 2027009-2025-02399.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874034 ↗MalfunctionDec 19, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT "WHEN PLUGGED IN THE CAMERA TO THE BOX THE SCREEN DOES NOT SHOW AN IMAGE AND NONE OF THE FEATURE'S WORK". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-02382.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853577 ↗MalfunctionOct 15, 2025Optical Problem; Optical Problem
THE FOLLOWING WAS REPORTED: "MISSING CONNECTION PINS INSIDE CAMERA PORT. DISCOVERED WHEN IMAGE STARTED FLICKERING DURING A CASE. NO PATIENT HARM. CASE WAS ABLE TO BE FINISHED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303141 ↗MalfunctionMar 9, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PER CONVERSATION WITH KARL STORZ REPRESENTATIVE AND THE FACILITY, AFTER A SEPTORHINOPLASTY PROCEDURE A "SMALL REDDISH BLEMISH" WAS NOTED POST OP WITH NO AWARENESS TO A PATIENT FOLLOW UP.
Patient problems: Superficial (First Degree) Burn
MAUDE report 11448893 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.