VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700Recalls & reported problems

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

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170433313), received between Aug 5, 2024 and Sep 25, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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/Image3
Communication or Transmission Problem2
Misfocusing2
Poor Quality Image2
Break1
Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported an Unspecified Code Scope malfunction error message during an inspection for use involving an Olympus Video System Center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899138 ↗
MalfunctionJul 20, 2026Break; Material Deformation
THE CUSTOMER RETURNED THE VIDEO SYSTEM CENTER, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, REAR PANEL DEFORMED AND FRONT PANEL DAMAGED WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25876510 ↗
MalfunctionApr 17, 2026No Display/Image
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909787 ↗
MalfunctionFeb 5, 2026Poor Quality Image
IT WAS REPORTED THE VIDEO SYSTEM CENTER DISPLAYED GREEN IMAGE. THE EVENT OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267509 ↗
MalfunctionDec 8, 2025Misfocusing; Misfocusing
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742477 ↗
MalfunctionDec 4, 2025Misfocusing; Misfocusing
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716361 ↗
MalfunctionNov 5, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DISPLAYED E213 ERROR ISSUE DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476524 ↗
MalfunctionOct 17, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A PIXILATED IMAGE. THE ISSUE WAS IDENTIFIED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325146 ↗
MalfunctionNov 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE 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 20652002 ↗
MalfunctionAug 5, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE VIDEO SYSTEM CENTER HAD NO IMAGE (APPEARING WHITE). THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19914735 ↗

Device details

UDI-DI	`04953170433313`
Brand	VISERA ELITE III VIDEO SYSTEM CENTER
Model	OLYMPUS OTV-S700
Catalog no.	N6158040
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Class	Class 2
FDA submission	None listed
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	Feb 17, 2026

Device type (GMDN): Endoscopic video image processing unit

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

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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