VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300Recalls & reported problems

All models of VISERA ELITE II VIDEO SYSTEM CENTER (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus VISERA Elite II video system is the central unit that processes images from endoscopes. Many reports describe communication failures and blank or abnormal displays, often found during inspection before use. The 158 reports include no deaths and no injuries. 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: 158
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 04953170386060), received between Jan 11, 2022 and Nov 18, 2025 — classified as 158 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (50 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

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

Most reported problems

Device problems

Communication or Transmission Problem50
No Display/Image44
Electrical /Electronic Property Problem11
Output Problem11
Display or Visual Feedback Problem8
Defective Component7
Poor Quality Image7
Erratic or Intermittent Display3

Patient problems

No Clinical Signs, Symptoms or Conditions158
Electric Shock1

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD A LOOSENESS IN THE SOCKET, CAUSING AN UNSTABLE CONNECTION. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583879 ↗
MalfunctionNov 17, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568987 ↗
MalfunctionSep 8, 2025Output Problem; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED LIGHT-EMITTING DIODE UNIT HAS CARBONIZED, CAUSING THE LIGHT INTENSITY OF THE GENERAL LIGHTING TO FAIL TO MEET THE STANDARD VALUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991819 ↗
MalfunctionAug 29, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922311 ↗
MalfunctionJul 28, 2025Intermittent Loss of Power; Intermittent Loss of Power
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22639454 ↗
MalfunctionJul 28, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE HAD INTERMITTENT IMAGE NOISE. THE EVENT OCCURRED DURING SET UP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630549 ↗
MalfunctionFeb 19, 2025Image Display Error/Artifact; Image Display Error/Artifact
DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER EXHIBITED AN ABNORMAL IMAGE FROM ALL THE OUTPUT PORTS DUE TO A PRINTED CIRCUIT BOARD FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412949 ↗
MalfunctionFeb 11, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A E333 ERROR. THE ISSUE OCCURRED AT INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356612 ↗
MalfunctionDec 27, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ERROR 333. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028227 ↗
MalfunctionDec 27, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING PREPARATION BEFORE USE THE SUBJECT DEVICE DISPLAYED ABNORMAL NOISE ON THE SCREEN, AND IT WAS UNABLE TO WORK NORMALLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026271 ↗
MalfunctionNov 15, 2024No Device Output; No Device Output
IT WAS REPORTED, THE VISERA ELITE II VIDEO SYSTEM CENTER TOUCH PANEL WAS NOT FUNCTIONING. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694185 ↗
MalfunctionSep 19, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE VIDEO SYSTEM CENTER EXHIBITED AN INTERMITTENT DISPLAY ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20264112 ↗
MalfunctionSep 18, 2024No Display/Image; Output Problem; No Display/Image; Output Problem
IT WAS REPORTED THE VIDEO SYSTEM CENTER HAD NO IMAGE AND THE SCREEN DID NOT LOAD UP. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252458 ↗
MalfunctionSep 17, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE VIDEO SYSTEM CENTER HAD ERROR E333. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20242621 ↗
MalfunctionAug 22, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THAT THE TOUCH DISPLAY WAS NOT WORKING FOR THE VIDEO SYSTEM CENTER. THE ISSUE OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030588 ↗
MalfunctionAug 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEO SYSTEM CENTER HAD A LIGHT GUIDE CONNECTION DETECTION FUNCTION FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19962676 ↗
MalfunctionAug 5, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE VIDEO SYSTEM CENTER¿S SCREEN WENT BLACK DURING AN UNSPECIFIED PROCEDURE AND DISPLAYED AN E226 SCOPE COMMUNICATION ERROR. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19914274 ↗
MalfunctionJul 18, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19770419 ↗
MalfunctionJun 12, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE VIDEO SYSTEM CENTER HAD ERROR E105. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519340 ↗
MalfunctionJun 4, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER SOCKETS ARE DAMAGING THE PADDLE OF THE SCOPES AND CAMERA HEAD. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19464384 ↗
MalfunctionJun 1, 2024Failure to Power Up; Failure to Clean Adequately; Failure to Power Up; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEO SYSTEM CENTER EXHIBITED THAT IT WAS UNABLE TO POWER UP THE UNIT DUE TO DEFECTIVE POWER SUPPLY UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19442744 ↗
MalfunctionMay 10, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD AN ERROR CODE E333 (TOUCH PANEL ERROR) DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288223 ↗
MalfunctionMay 8, 2024Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED TO OLYMPUS, THAT THE VIDEO SYSTEM CENTER HAD A BLURRY IMAGE AND EXPERIENCED AN E227 SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271944 ↗
MalfunctionApr 29, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED, THE VIDEO SYSTEM CENTER HAD E333 ERROR. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201431 ↗
MalfunctionApr 23, 2024Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT THE VIDEO SYSTEM CENTER EXHIBITED AN IMAGE PROCESSOR ERROR (E230ERROR). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169058 ↗

Device details

UDI-DI	`04953170386060`
Brand	VISERA ELITE II VIDEO SYSTEM CENTER
Model	OLYMPUS OTV-S300
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Class	Class 2
FDA submission	K193026
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 15, 2024

Device type (GMDN): Endoscopic video image processing/light source system

A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.

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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