VISERA 4K UHD CAMERA CONTROL UNITRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,029
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 2 models of VISERA 4K UHD CAMERA CONTROL UNIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 1,029 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2020 and Sep 28, 2026 — classified as 9 injuries, 1,020 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (410 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VISERA 4K UHD CAMERA CONTROL UNIT problems
Device problems
- Communication or Transmission Problem410
- No Display/Image224
- Output Problem136
- Electrical /Electronic Property Problem73
- Display or Visual Feedback Problem36
- Image Display Error/Artifact34
- Erratic or Intermittent Display26
- Poor Quality Image25
Patient problems
- No Clinical Signs, Symptoms or Conditions1,010
- No Consequences Or Impact To Patient8
- No Patient Involvement7
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Arrhythmia1
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
VISERA 4K UHD CAMERA CONTROL UNIT models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Laparoscope, general & plastic surgery777 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Endoscope, accessories, narrow band spectrum252 reports
Recent VISERA 4K UHD CAMERA CONTROL UNIT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Communication or Transmission Problem; Activation Failure
The customer reported the video system center front panel liquid crystal display and the screen did not proceed to the main screen during inspection for use . During the initial evaluation of the device error code E116 was observed. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923510 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
The customer reported the video system center had intermittent error E116 during Service / Maintenance (not in a clinical setting). No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841085 ↗MalfunctionSep 15, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781862 ↗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 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502667 ↗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 31, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107733 ↗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 20, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER EXPERIENCED ERROR CODE E116. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25227854 ↗MalfunctionMay 19, 2026Communication or Transmission Problem; Activation Failure
IT WAS REPORTED THAT, THE VIDEO SYSTEM CENTER EXHIBITED FAILURE TO BOOT UP WHEN POWERED ON AND SCOPE ERROR (E116). THE ISSUE WAS IDENTIFIED AT THE TIME OF INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217461 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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