VIDEO SYSTEM OTV-SI (UDI 04953170169885)Recalls & reported problems

Olympus Medical Systems Corp. · "OTV-SI(A) OTV-SI OFFICE VID SYS W/O PUMP" · Class 2

Quick summary

This Olympus OTV-SI video system is an endoscopic video imaging system. The 40 reports that name it mostly describe the screen not displaying an image, along with power or connection problems, with no injuries or deaths. 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: 40
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04953170169885), received between Jun 10, 2021 and May 20, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (12 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/Image12
Connection Problem5
Loose or Intermittent Connection5
Failure to Power Up4
Electrical /Electronic Property Problem2
Loss of Power2
No Visual Prompts/Feedback2
Poor Quality Image2

Patient problems

No Clinical Signs, Symptoms or Conditions40

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 20, 2026No Display/Image; Poor Quality Image
THE CUSTOMER REPORTED A STATIC SCREEN WHEN THE DEVICE WAS TURNED ON AND PLUGGED IN A SCOPE, LIKE THERE WAS FEEDBACK AND FUZZ. THERE WAS NO IMAGE, A BLACK AND BLUE STATIC DURING SET UP INVOLVING AN OLYMPUS VIDEO SYSTEM CENTER. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229437 ↗
MalfunctionMay 1, 2026No Display/Image; Connection Problem
IT WAS REPORTED THAT DURING INSPECTION FOR USE, THE VIDEO SYSTEM CENTER DID NOT DISPLAY AN IMAGE ON THE MONITOR UNLESS THE SCOPE CONNECTOR WAS JIGGLED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058857 ↗
MalfunctionMay 1, 2026No Display/Image; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057931 ↗
MalfunctionFeb 19, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DID NOT DISPLAY ENDOSCOPIC IMAGE. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388892 ↗
MalfunctionFeb 17, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE ON THE SCREEN. THE ISSUE WAS IDENTIFIED DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364224 ↗
MalfunctionFeb 17, 2026Crack; Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER HAD BURNT LAMP AND WEAR ON VIDEO CONNECTOR UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364041 ↗
MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879117 ↗
MalfunctionNov 6, 2025Degraded; Degraded
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 23488002 ↗
MalfunctionOct 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED THE VIDEO SYSTEM HAD THE LIGHT POST PLUG WAS LOOSE. THE ISSUE WAS FOUND DURING A CYSTOSCOPY DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343867 ↗
MalfunctionAug 5, 2025No Display/Image; Loose or Intermittent Connection; No Display/Image; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713583 ↗
MalfunctionJul 21, 2025Poor Quality Image; Connection Problem; Poor Quality Image; Connection Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE CONNECTOR FOR THE SCOPES WAS CAUSING IMAGE PROBLEMS, DURING AN UNSPECIFIED CYSTOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560598 ↗
MalfunctionJun 19, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE VIDEO SYSTEM EXPERIENCED THE CABLE WAS RIPPED AND THE STAFF USED WHAT LOOKS LIKE A BANDAGE TO HOLD IT IN PLACE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289873 ↗
MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DISPLAYED A LAMP ERROR DURING SETUP FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908456 ↗
MalfunctionMar 27, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD LOSE SIGNAL WHENEVER THE SCOPE GETS TOUCHED. THE ISSUE WAS FOUND DURING SET UP OF CYSTOSCOPY DIAGNOSTIC PROCEDURE. IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710834 ↗
MalfunctionMar 21, 2025Connection Problem; Connection Problem
IT WAS REPORTED THE VIDEO SYSTEM CENTER EXPERIENCED THAT THE SCOPE CONNECTOR LOST SIGNAL WHENEVER THE SCOPE WAS TOUCHED, DURING SEDATION FOR A DIAGNOSTIC CYSTOSCOPY. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662345 ↗
MalfunctionMar 14, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE PRESENTS THE FOLLOWING MALFUNCTION: THE SCREEN WENT BLACK. THE MALFUNCTION OCCURRED DURING A DIAGNOSTIC CYSTOSCOPY, WHICH WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21611336 ↗
MalfunctionMar 11, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE INSPECTED DEVICE PRESENTED THAT THE VIDEO SOURCE PIECE IS VERY LOOSE AND DOES NOT STAY ON. HE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572749 ↗
MalfunctionFeb 18, 2025Intermittent Communication Failure; Intermittent Communication Failure
IT WAS REPORTED THAT THE VIDEO SYSTEM WAS NOT GETTING VIDEO SIGNAL CONSISTENTLY. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405537 ↗
MalfunctionJan 7, 2025Power Problem; Power Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD A BAD POWER CORD. THE EVENT OCCURRED DURING SET UP FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093226 ↗
MalfunctionNov 25, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A LAMP ERROR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772083 ↗
MalfunctionNov 5, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THE VIDEO SYSTEM CENTER LAMP WOULD TURN ON FOR A FEW SECONDS AND THEN IT SHUTS OFF AND CANNOT BE REIGNITED. THE ISSUE OCCURRED DURING PRIOR TO THE PROCEDURE. THE CUSTOMER WAS INFORMED THE LAMP WILL NEED TO BE CHANGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613808 ↗
MalfunctionAug 22, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED, THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE OCCURRED, DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20043598 ↗
MalfunctionAug 19, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER'S LAMP DOES NOT LIGHT. 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 19999770 ↗
MalfunctionNov 8, 2023Optical Problem; Optical Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO SYSTEM'S ILLUMINATION LIGHT ADJUSTMENT FUNCTION IS NOT PROPERLY CONTROLLED, AND THE ILLUMINATION LIGHT IS TOO BRIGHT. THE ISSUE WAS FOUND DURING A DIAGNOSTIC CYSTOSCOPY AND A STENT REMOVAL. THE PROVIDER HAD A DIFFICULT TIME NAVIGATING AND VIEWING THE INSIDE OF THE PATIENT'S BLADDER DUE TO EXTREME BRIGHTNESS. REMOVAL OF A KIDNEY STENT WAS ESPECIALLY DIFFICULT. THE PROCEDURE WAS DELAYED BUT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18097750 ↗
MalfunctionJun 26, 2023No Display/Image; No Display/Image
A CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A MALFUNCTION OF THE CONTACT PARTS. THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17199937 ↗

Device details

UDI-DI	`04953170169885`
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.