VIDEO SYSTEM OTV-SI (UDI 04953170170461)Recalls & reported problems

Olympus Medical Systems Corp. · "OTV-SI(B) OTV-SI OFFICE VID SYSTM W/PUMP" · Class 2

Quick summary

This Olympus OTV-SI office video system is a video unit for endoscopes. Its 143 reports often describe no picture, a flickering display, lamp errors or poor image quality, and most report no patient harm. There are no deaths and no injuries. No recalls name this device. Reports fell to 1 in the last 12 months from 7 before.

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: 143
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 04953170170461), received between Apr 6, 2020 and Mar 2, 2026 — classified as 143 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (32 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

No Display/Image32
Erratic or Intermittent Display11
Communication or Transmission Problem10
Optical Problem10
Poor Quality Image9
Display or Visual Feedback Problem8
Output Problem8
No Visual Prompts/Feedback7

Patient problems

No Clinical Signs, Symptoms or Conditions113
No Patient Involvement17
No Consequences Or Impact To Patient16

Recent adverse event reports

The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 2, 2026Communication or Transmission Problem
IT WAS REPORTED THE VIDEO SYSTEM WAS GETTING A LAMP ERROR B. WAS NOT ABLE TO CLEAR IT EVEN THOUGH LAMP A WAS WORKING. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24488365 ↗
MalfunctionOct 28, 2025Activation Problem; Activation Problem
IT WAS OBSERVED DURING THE DEVICE INVESTIGATION THAT THE SUBJECT DEVICE EXHIBITED A LAMP A ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407982 ↗
MalfunctionMay 23, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22078937 ↗
MalfunctionMay 9, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE DISPLAYED LAMP A ERROR DURING A DIAGNOSTIC NASOPHARYNX SCOPE EXAM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995027 ↗
MalfunctionMay 2, 2025Optical Problem; Optical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953620 ↗
MalfunctionApr 24, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED NO INPUT ON THE COMBINATION DEVICE USED ALONG WITH IT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905087 ↗
MalfunctionFeb 7, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM EXHIBITED CONTACT PART ON THE VIDEO CONNECTOR RECEPTACLE IS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332933 ↗
MalfunctionNov 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758474 ↗
MalfunctionOct 17, 2024Output Problem; Output Problem
IT WAS REPORTED, THE VIDEO SYSTEM CENTER EXHIBITED A LAMP ERROR. IT IS UNKNOWN, WHEN THE REPORTED ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478112 ↗
MalfunctionOct 16, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE VIDEO SYSTEM DISPLAYED A LAMP ERROR THAT WOULD NOT DISAPPEAR. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20463327 ↗
MalfunctionOct 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT, THE VIDEO SYSTEM HAD BLACK LINES APPEAR ON THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20430410 ↗
MalfunctionSep 25, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE VIDEO SYSTEM HAD A LAMP ERROR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301494 ↗
MalfunctionSep 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THE VIDEO SYSTEM EXHIBITED INTERMITTENT VIDEO OUT PROBLEM. THE ISSUE OCCURRED, DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202482 ↗
MalfunctionSep 4, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THE VIDEO SYSTEM CENTER'S HALOGEN LAMP IS WORN OUT AND DOES NOT LIGHT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20135134 ↗
MalfunctionAug 21, 2024Output Problem; Output Problem
IT WAS REPORTED, THE VIDEO SYSTEM EXHIBITED ERROR IN LAMP A. THERE WERE NO REPORTS OF PATIENT HARM. WHILE SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER WAS ADVISED TO START BY CHANGING THE LAMP. THE CUSTOMER WAS THEN TRANSFERRED TO CUSTOMER SERVICE TO PLACE AN ORDER FOR A LAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017593 ↗
MalfunctionAug 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THE VIDEO SYSTEM SMELL LIKE IT WAS BURNING WHEN THE POWER WAS ON. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19924914 ↗
MalfunctionAug 5, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEO SYSTEM EXHIBITED A LAMP ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910072 ↗
MalfunctionJul 10, 2024Failure to Power Up; No Visual Prompts/Feedback; Failure to Power Up; No Visual Prompts/Feedback
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEO SYSTEM EXHIBITED THE POWER DOES NOT TURN ON DUE TO A FAULTY INTERLOCK SWITCH AND BOTH LAMPS ARE BLOWN DUE TO A LAMP ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711438 ↗
MalfunctionJun 28, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THAT THE VIDEO SYSTEM ANGLE OF THE SCOPE INSERTION PORT SOMETIMES PREVENTED THE IMAGE FROM BEING DISPLAYED ON THE MONITOR. THE ISSUE OCCURRED, DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19636261 ↗
MalfunctionMay 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
THE EVENT OCCURRED DURING A DIAGNOSTIC PROCEDURE THAT WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19283212 ↗
MalfunctionFeb 23, 2024No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER EXHIBITED THAT THE AUTO DISPLAY DOES NOT LIGHT UP DUE TO FRONT PANEL FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18767778 ↗
MalfunctionFeb 22, 2024Output Problem; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM HAD A LAMP A ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18761199 ↗
MalfunctionJan 28, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO SIGNAL OR IMAGE ON THE LIGHT GUIDE MONITOR. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE PROCEDURE WAS DELAYED 24 HOURS BUT THERE WERE NO REPORTS OF PATIENT HARM OR MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592916 ↗
MalfunctionJan 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE IMAGE ON THE VIDEO PROCESSOR WAS FREEZING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592354 ↗
MalfunctionJan 22, 2024Defective Component; Defective Component
THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO SYSTEM CENTER HAD A DEAD BATTERY. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE LAMP A ERROR DUE TO LAMP A DAMAGE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18555555 ↗

Device details

UDI-DI	`04953170170461`
Brand	VIDEO SYSTEM
Model	OTV-SI
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	Not in Commercial Distribution
Record updated	Jan 12, 2024

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.