VIDEO SYSTEM OTV-SI (UDI 04953170169892)Recalls & reported problems

Quick summary

This Olympus OTV-SI video system is the unit that shows images from endoscopes used in digestive and urinary procedures. Many of the 113 reports describe no image on the screen, electrical faults, poor or flickering images, and units failing to power up. The reports include no injuries and no deaths, and 7 note no consequences to the patient. 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: 113
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 04953170169892), received between Jul 16, 2020 and Apr 8, 2026 — classified as 113 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (35 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/Image35
Electrical /Electronic Property Problem17
Poor Quality Image13
Erratic or Intermittent Display10
Break8
Failure to Power Up5
No Device Output5
Display or Visual Feedback Problem4

Patient problems

No Clinical Signs, Symptoms or Conditions106
No Consequences Or Impact To Patient7
Insufficient Information1

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 8, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER EXHIBITED BULB B WAS DAMAGED AND NOT LIGHTING UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818003 ↗
MalfunctionMar 16, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER HAD FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603229 ↗
MalfunctionFeb 25, 2026Display or Visual Feedback Problem; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER INITIALLY DISPLAYED A BLACK-AND-WHITE IMAGE, WHICH LATER PROGRESSED TO A COMPLETE IMAGE FAILURE. THE SCOPE-VIDEO CONNECTION SOCKET WAS ALSO PROBABLY DEFECTIVE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444575 ↗
MalfunctionNov 20, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607561 ↗
MalfunctionNov 5, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THE SUBJECTED DEVICE HAD DARK IMAGE. THE EVENT OCCURRED DURING SERVICE / MAINTENANCE . THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479235 ↗
MalfunctionOct 16, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310572 ↗
MalfunctionSep 2, 2025Poor Quality Image; Activation Problem; Poor Quality Image; Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FLICKERING IN OUTPUT IMAGE AND THE LAMP IS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936917 ↗
MalfunctionJun 19, 2025No Device Output; No Device Output
IT WAS REPORTED THE OPTICAL ACC HAS NO LIGHT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 22292741 ↗
MalfunctionJun 11, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN OCCASIONAL NO IMAGE. THE ISSUE WAS IDENTIFIED DURING THE REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187411 ↗
MalfunctionJun 9, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170860 ↗
MalfunctionMay 14, 2025Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22020209 ↗
MalfunctionApr 24, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM EXHIBITED NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898210 ↗
MalfunctionMar 31, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD A BLACK IMAGE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732840 ↗
MalfunctionJan 23, 2025Erratic or Intermittent Display; Poor Quality Image; Erratic or Intermittent Display; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223789 ↗
MalfunctionDec 30, 2024Loose or Intermittent Connection; Activation Problem; Loose or Intermittent Connection; Activation Problem
THE REPORT INDICATES THAT THE SUBJECT DEVICE HAD LOOSE INTERFACE, AND THE LIGHT COULD NOT BE TURNED ON. THE ISSUE WAS FOUND DURING THE REPROCESSING OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21044027 ↗
MalfunctionDec 3, 2024No Display/Image; No Display/Image
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE VIDEO SYSTEM EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832297 ↗
MalfunctionNov 7, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE VIDEO SYSTEM¿S IMAGE WAS FLICKERING. THE ISSUE WAS FOUND DURING PREPARATION BEFORE A 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 20636620 ↗
MalfunctionOct 11, 2024No Display/Image; Loose or Intermittent Connection; No Display/Image; Loose or Intermittent Connection
IT WAS REPORTED THE VIDEO SYSTEM HAD NO IMAGE AND A LOOSE CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434256 ↗
MalfunctionOct 2, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A PREPARATION FOR USE, THE VIDEO SYSTEM HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20356025 ↗
MalfunctionAug 26, 2024Output Problem; Output Problem
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE VIDEO SYSTEM HAD LAMP B NOT WORKING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20063169 ↗
MalfunctionAug 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20047698 ↗
MalfunctionJul 23, 2024No Device Output; No Device Output
IT WAS REPORTED THE VIDEO SYSTEM LIGHT BULB WAS BLOWING EVERY TEN DAYS. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804880 ↗
MalfunctionJun 12, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THE VIDEO SYSTEM POWER TURNED OFF UNEXPECTEDLY. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521247 ↗
MalfunctionMar 22, 2024Break; Break
IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION, THE VIDEO SYSTEM EXHIBITED A DAMAGED LAMP A. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961366 ↗
MalfunctionMar 18, 2024Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED TO OLYMPUS THE VIDEO SYSTEM WAS FLICKERING INTERMITTENTLY DURING REPROCESSING. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT UNDER ANESTHESIA, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT NOR ANY MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18924132 ↗

Device details

UDI-DI	`04953170169892`
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.