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

Olympus Medical Systems Corp. · VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300 · Class 2

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

Quick summary

This Olympus VISERA ELITE II video system center, which shows images from endoscopes, has 528 adverse event reports, with no deaths and 4 injuries. Most reports describe a black or frozen image, communication errors with the scope, and dim or poor-quality pictures, and some procedures had to be completed on a backup device. No recalls name this device. Reports fell from 28 in the prior 12 months to 11 in the last 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: 529
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 529 adverse event reports that list this exact device (DI 04953170386077), received between Sep 12, 2020 and Sep 30, 2026 — classified as 4 injuries, 525 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (177 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

No Display/Image177
Communication or Transmission Problem125
Output Problem83
Display or Visual Feedback Problem26
Poor Quality Image25
Electrical /Electronic Property Problem22
Break16
Failure to Power Up16

Patient problems

No Clinical Signs, Symptoms or Conditions526
No Consequences Or Impact To Patient3
Insufficient Information1

Recent adverse event reports

The 25 most recent of 529 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026No Display/Image; Poor Quality Image
The customer reported that a fuzzy or snowy image and no image display were observed when the device was plugged in during inspection for use involving an Olympus video system center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941900 ↗
MalfunctionAug 25, 2026No Display/Image
The customer reported a black image in the video system center during a cystoscopy therapeutic procedure which was completed using a competitor's Olympus device. While the patient was under sedation, a procedure delay was observed. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50434459 ↗
MalfunctionAug 3, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50109206 ↗
MalfunctionJul 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055870 ↗
MalfunctionJun 23, 2026Poor Quality Image
THE CUSTOMER REPORTED THAT BRIGHTNESS WAS A BIT DARK DURING INSPECTION FOR USE OF AN OLYMPUS VIDEO SYSTEM CENTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598876 ↗
MalfunctionMay 12, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER EXHIBITED SCOPE COMMUNICATION ERROR E226. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148017 ↗
MalfunctionMar 30, 2026Image Display Error/Artifact
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD A VIDEO IMAGE FREEZE FOR SEVERAL SECONDS. THE ISSUE OCCURRED DURING A FLEXIBLE SIGMOIDOSCOPY PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THE INTENDED PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715112 ↗
MalfunctionMar 30, 2026Poor Quality Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD VIDEO IMAGE THAT WOULD FREEZE. THE ISSUE WAS FOUND DURING SEDATION OF A FLEXIBLE SIGMOIDOSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713972 ↗
MalfunctionMar 26, 2026Poor Quality Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER EXPERIENCED A FROZEN VIDEO IMAGE. THE ISSUE OCCURRED DURING A FLEXIBLE SIGMOIDOSCOPY PROCEDURE, WHICH WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WAS A DELAY IN THE PROCEDURE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697581 ↗
MalfunctionDec 12, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791190 ↗
MalfunctionDec 12, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790655 ↗
MalfunctionNov 10, 2025Output Problem; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510596 ↗
MalfunctionOct 31, 2025No Display/Image; Connection Problem; No Display/Image; Connection Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD FAILED CONNECTION 2 OR 3 TIMES AND THE IMAGE WOULD GO BLACK COMPLETELY. THE ISSUE OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435408 ↗
MalfunctionOct 23, 2025Output Problem; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED UNABLE TO LOGIN SERVICE MODE INTERMITTENTLY DUE TO FAULTY TOUCH SCREEN PANEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368343 ↗
MalfunctionJul 17, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE POWER SUPPLY INPUT CONNECTOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535600 ↗
MalfunctionJul 9, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22462499 ↗
MalfunctionJun 23, 2025Output Problem; Output Problem
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED E333 ERROR. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310998 ↗
MalfunctionMay 16, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE VIDEO SYSTEM CENTER PRESENTED A COMMUNICATION ERROR E226. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036572 ↗
MalfunctionMay 8, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A POOR IMAGE QUALITY (NO VIDEO IMAGE DISPLAYED WHEN CONNECTED TO OTV-S300), THE ISSUE OCCURRED DURING INSPECTION FOR USE, BEFORE THE PATIENT ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985477 ↗
MalfunctionApr 28, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT HAD BROKEN VIDEO CONNECTOR. THE ISSUE WAS IDENTIFIED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919059 ↗
MalfunctionMar 27, 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 21706844 ↗
MalfunctionMar 26, 2025Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection
IT WAS REPORTED THE CONNECTOR SOCKET OF THE VIDEO SYSTEM CENTER WAS BROKEN DURING SEDATION (DEVICE INSIDE PATIENT) FOR A THERAPEUTIC CYSTOSCOPY WITH UTREROSCOPY PROCEDURE. THE PROCEDURE WAS DELAYED FOR LESS THAN 30 MIN AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21704452 ↗
MalfunctionFeb 24, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21449694 ↗
MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21211629 ↗
MalfunctionJan 15, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21162396 ↗

Device details

UDI-DI	`04953170386077`
Brand	VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
Model	OLYMPUS OTV-S300
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	K202646
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 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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