VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400 (UDI 04953170374623)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of VISERA 4K UHD CAMERA CONTROL UNIT (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Visera camera control unit is the video processor that connects endoscope cameras to monitors. Its 250 reports often describe no image or display, communication errors, and video output problems. The reports include 1 injury 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
- 252
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 04953170374623), received between Dec 30, 2020 and Sep 15, 2026 — classified as 1 injury, 251 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (94 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem94
- No Display/Image62
- Output Problem24
- Electrical /Electronic Property Problem16
- Image Display Error/Artifact11
- Poor Quality Image11
- Connection Problem10
- Erratic or Intermittent Display9
Patient problems
- No Clinical Signs, Symptoms or Conditions246
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777181 ↗MalfunctionSep 10, 2026Erratic or Intermittent Display
The customer reported that the lower left quadrant keeps dropping out (flickering in and out) during a procedure involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704707 ↗MalfunctionAug 27, 2026No Display/Image
The customer reported that the Video System Center displayed no image during inspection for use. During the initial evaluation of the returned device, it was observed that Serial Digital Interface (SDI) one and SDI two had no output. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477359 ↗MalfunctionAug 14, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253035 ↗MalfunctionJul 7, 2026Activation Failure
THE CUSTOMER REPORTED THE SCREEN GOES ON AND OFF DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS VIDEO SYSTEM CENTER. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25737873 ↗MalfunctionJun 17, 2026Poor Quality Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DISPLAYED AN INTERMITTENT IMAGE. THE ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25541555 ↗MalfunctionMay 26, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED THAT IT DOESN'T WORK DURING INSPECTION FOR USE INVOLVING AN OLYMPUS VIDEO SYSTEM CENTER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278619 ↗MalfunctionMay 24, 2026Output Problem
THE CUSTOMER REPORTED HIGH DEFINITION-SERIAL DIGITAL INTERFACE VIDEO OUTPUTS ARE BAD AN OLYMPUS VIDEO SYSTEM CENTER. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267150 ↗MalfunctionMay 7, 2026Output Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD E116 (COMMUNICATION ERROR). THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117731 ↗MalfunctionMay 1, 2026Connection Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER PREVENTING A CAMERA FROM CONNECTING. THE ISSUE WAS FOUND DURING A CYSTOSCOPY THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057684 ↗MalfunctionApr 30, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER EXHIBITED ERROR CODE E117. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050121 ↗MalfunctionApr 28, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020623 ↗MalfunctionApr 16, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24894976 ↗MalfunctionMar 25, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD A BLACK SCREEN. THE ISSUE WAS FOUND DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688855 ↗MalfunctionMar 16, 2026Communication or Transmission Problem
IT WAS REPORTED THE VIDEO SYSTEM CENTER TOUCHSCREEN WAS NOT WORKING RIGHT. THE ISSUE OCCURRED DURING MAINTENANCE, NOT IN A CLINICAL SETTING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607839 ↗MalfunctionMar 13, 2026Poor Quality Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD A LINE THAT APPEARED WHEN THE CAMERA WAS MOVED. THE ISSUE WAS FOUND DURING SEDATION OF A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590571 ↗MalfunctionJan 22, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER EXHIBITED ERROR CODE E116, AND E117. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24153117 ↗MalfunctionJan 20, 2026Erratic or Intermittent Display; Poor Quality Image; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD IMAGE LOSS AND DISPLAY OF COLOR BARS, ADDITIONALLY THE PADDLE CONNECTION WAS FAILING. THE ISSUES WERE FOUND DURING A DIAGNOSTIC PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24122507 ↗MalfunctionJan 7, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988950 ↗MalfunctionJan 6, 2026Image Display Error/Artifact
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974218 ↗MalfunctionJan 5, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23965858 ↗MalfunctionDec 31, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER SWITCH WHICH THE FIBER WAS SUPPOSED TO ACTIVATE TO ENGAGE THE LIGHTS DID NOT FUNCTION. THE ISSUE WAS FOUND DURING SEDATION OF AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933087 ↗MalfunctionDec 23, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23883033 ↗MalfunctionNov 26, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655951 ↗MalfunctionNov 25, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD ERROR CODE E116. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647987 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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