IMAGE1 S CONNECT TC201USRecalls & reported problems
Karl Storz GmbH & Co. KG · IMAGE1 S CONNECT II · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the Karl Storz IMAGE1 S CONNECT II, the video display unit that shows the view from a surgical endoscope. The reports mostly describe the picture going blank or the unit failing to recognize the camera, sometimes causing procedures to be delayed. There are 31 reports, 5 injuries and no deaths. No recalls name this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04048551422625), received between Mar 9, 2021 and Sep 28, 2026 — classified as 5 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (10 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
Most reported problems
Device problems
- Display or Visual Feedback Problem10
- No Display/Image10
- Insufficient Device Problem Information4
- Circuit Failure3
- Erratic or Intermittent Display3
- Loose or Intermittent Connection2
- Optical Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926222 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926221 ↗MalfunctionSep 16, 2026No Display/Image
According to the information received, no image after initial start up. Both the AIDA and the monitor showed no image signal or searching for image. A power cycle resolved it, but this is the third time this unit has had this issue would like to have it evaluated at the video card. No death or (unanticipated) serious deterioration in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789754 ↗MalfunctionSep 16, 2026No Display/Image
According to the information received, no image after initial start up. Both the AIDA and the monitor showed no image signal or searching for image. A power cycle resolved it, but this is the third time this unit has had this issue would like to have it evaluated at the video card. No death or (unanticipated) serious deterioration in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789753 ↗MalfunctionSep 16, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789751 ↗InjuryApr 9, 2026No Display/Image
ACCORDING TO THE INFORMATION RECEIVED THE TC304 WOULD NOT RECOGNIZE CAMARA AND WHEN IT DID THE SCREEN WAS GRAY/GREEN. CUSTOMER IS NOT SURE IF THE ISSUE IS WITH THE TC304 OR TC201. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS DELAYED BY OVER 30 MINUTES. CROSS REFERENCE MDR: 2027009-2026-00784.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835201 ↗MalfunctionMar 23, 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: 2027009-2026-00745.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670065 ↗MalfunctionMar 23, 2026No Display/Image
IT WAS REPORTED THAT "WHEN CONNECTED, THE IMAGE1 S REGISTERS THE SCOPE IS CONNECTED, READS OUT IT'S SERIAL INFORMATION, BUT PRODUCES NO IMAGE. DATA FOR THE ATTACHED CAMERA IS REGISTERED IN THE MODULE INFORMATION TAB". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669177 ↗MalfunctionFeb 19, 2026No Display/Image
IT WAS REPORTED THAT THERE WAS NO SIGNAL. THE DISPLAY GOES OUT AND THE AIDA SAYS NO SIGNAL AND WHEN WE PUT ANOTHER BOX EVERYTHING COMES UP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390477 ↗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 24203159 ↗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 24203155 ↗MalfunctionJan 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: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00166, 2027009-2026-00167.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202958 ↗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: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00166, 2027009-2026-00168.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202931 ↗MalfunctionDec 22, 2025Circuit Failure; Insufficient Device Problem Information; Circuit Failure; 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: 2027009-2025-02399. 2027009-2025-02400.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874033 ↗MalfunctionDec 22, 2025Circuit Failure; Insufficient Device Problem Information; Circuit Failure; 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: 2027009-2025-02402. 2027009-2025-02403.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874032 ↗MalfunctionDec 22, 2025Circuit Failure; Insufficient Device Problem Information; Circuit Failure; 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: 2027009-2025-02405. 2027009-2025-02406.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874031 ↗MalfunctionDec 19, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
ACCORDING TO THE INFORMATION RECEIVED, IT WAS FLICKERING WHEN CONNECTED TO THE CAMERA. NO PATIENT INVOLVEMENT WAS REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853634 ↗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 FEATURES WORK". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-02383.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853615 ↗MalfunctionNov 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, UNIT IS GIVING ERROR MESSAGE "MENU TEMPORARILY UNAVAILABLE" PICTURE OF ERROR ATTACHED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660619 ↗MalfunctionNov 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, BOOT UP ERROR MESSAGE AND ASK FOR A RESTART. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660618 ↗MalfunctionSep 17, 2025Optical Problem; Optical Problem
THE FOLLOWING WAS REPORTED: "CUSTOMER'S IMAGE FLICKERS/ CUTS OUT OR HAS ELECTRICAL INTERFERENCE (IE - PURPLE/GREEN LINES AND/OR STATIC LINES)". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-01625.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077290 ↗MalfunctionAug 20, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE FOLLOWING WAS REPORTED: "DURING A CASE 30 - 45 MINUTES INTO THE CASE, THE IMAGE INTERMITTENTLY GOES IN AND OUT. SOMETIMES AS LONG AS 10 SECONDS. TROUBLE SHOOTING PERFORMED BY CHANGING CABLES AND CHANGING SECONDARY MONITORS AND THE CAMERA. STILL EXPERIENCED THE SAME ISSUE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22856466 ↗MalfunctionAug 6, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE FOLLOWING WAS REPORTED: "DURING A CASE 30 - 45 MINUTES INTO THE CASE, THE IMAGE INTERMITTENTLY GOES IN AND OUT. SOMETIMES AS LONG AS 10 SECONDS. TROUBLE SHOOTING PERFORMED BY CHANGING CABLES AND CHANGING SECONDARY MONITORS AND THE CAMERA. STILL EXPERIENCED THE SAME ISSUE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22732633 ↗MalfunctionAug 6, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE FOLLOWING WAS REPORTED: "CAMERA SHUT OFF DURING THE PROCEDURE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-01376.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22732594 ↗MalfunctionJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT "UNITS ARE GOING BLACK/BLANK WHEN A CAMERA IS PLUGGED IN. CUT OUT IN MIDDLE OF PROCEDURE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666437 ↗
Other Endoscope, neurological devices
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
- VS3-IR 161-0001Visionsense Ltd. · Endoscope, Neurological1 recall4 reports
- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 reports
- NA 1688410110Stryker Corporation · Endoscope, neurological8 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page