VIDEO SYSTEM OTV-SC (UDI 04953170136917)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus OTV-SC video system is the processor/display unit that connects to flexible endoscopes. The 55 reports mostly describe the unit showing no image at all, and sometimes lines or noise in the picture, or failing to power on, with problems typically found during inspection or reprocessing rather than during a procedure. There are no deaths and no injuries. Reports of no image rose from 4 in the earlier 12 months to 10 in the most recent 12 months. 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 04953170136917), received between Sep 25, 2020 and Sep 30, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (43 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
Most reported problems
Device problems
- No Display/Image43
- Poor Quality Image6
- Erratic or Intermittent Display3
- Break2
- Electrical /Electronic Property Problem2
- Failure to Power Up2
- Power Problem2
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image; No Device Output
The customer reported that the camera was not working. The issue occurred during inspection for use involving a Video System Center. Additionally, during the initial evaluation of the returned device and the onsite inspection observed that there was no image on the monitor. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949608 ↗MalfunctionMay 28, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM HAD NO FUNCTIONAL CAMERA. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319772 ↗MalfunctionMay 20, 2026Break; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER EXHIBITED NOISE/LINES IN THE IMAGE AND DEFECTIVE FRONT PANEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232413 ↗MalfunctionMay 7, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118817 ↗MalfunctionApr 6, 2026Failure to Power Up
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER WAS UNABLE TO POWER ON. THE ISSUE WAS FOUND DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792661 ↗MalfunctionMar 3, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495366 ↗MalfunctionFeb 9, 2026No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300522 ↗MalfunctionJan 8, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002712 ↗MalfunctionDec 10, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DID NOT DISPLAY ANY IMAGE. 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 23769279 ↗MalfunctionDec 4, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM HAD NO IMAGE WHEN CONNECTING THE CAMERA HEAD. 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 23717107 ↗MalfunctionNov 12, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532481 ↗MalfunctionOct 29, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23414656 ↗MalfunctionJun 25, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE VIDEO PROCESSOR HAD THE CAMERA DOES NOT LIT UP, THE MONITOR DISPLAYS NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329226 ↗MalfunctionFeb 24, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21452365 ↗MalfunctionNov 19, 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 20726239 ↗MalfunctionSep 24, 2024Break; No Display/Image; Break; No Display/Image
IT WAS REPORTED THAT THE VIDEO SYSTEM EXHIBITED FAILURE IN TRANSMITTING IMAGES AND HAD A DAMAGED CAMERA CABLE. 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 20296345 ↗MalfunctionSep 12, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE VIDEO SYSTEM HAD POWER ON FAILURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20197444 ↗MalfunctionJul 24, 2024No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED, THE VIDEO SYSTEM CENTER EXHIBITED NOISE/FLICKER WHEN CONNECTED TO THE SCOPE VIDEO CONNECTOR AND WHEN CONNECTED WITH THE COMPOSITE PORT THERE WAS NO IMAGE. CROSS CHECKED WITH ANOTHER SYSTEM AND WAS WORKING FINE WITH THE CUSTOMER'S CAMERA HEAD. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817262 ↗MalfunctionJul 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE VIDEO SYSTEM HAD NO IMAGE. THE ISSUE OCCURRED, DURING PREPARATION FOR USE. FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808333 ↗MalfunctionJun 27, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE VIDEO PROCESSOR EXHIBITED NO IMAGE DUE TO FAULTY POWER UNIT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629250 ↗MalfunctionJun 23, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE VIDEO SYSTEM HAD INTERMITTENT IMAGE AND SEVER NOISE OR FLICKER THAT THE ENDOSCOPIC IMAGE WAS NOT VISIBLE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19591714 ↗MalfunctionMay 13, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE VIDEO SYSTEM CENTER HAS AN IMAGE WITH STRIPES. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19300457 ↗MalfunctionFeb 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE VIDEO SYSTEM EXHIBITED IMAGE ISSUES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18760159 ↗MalfunctionJan 23, 2024No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO SYSTEM HAD A BLACK SCREEN. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A HYSTEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF DEVICE. THERE WAS NO DELAY REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18563516 ↗MalfunctionOct 23, 2023No Display/Image; No Display/Image
THE OLYMPUS FIELD SERVICE ENGINEER (FSE) (ON BEHALF OF THE CUSTOMER) REPORTED TO OLYMPUS THAT IMAGE WAS NOT COMING ON THE VIDEO SYSTEM. THE ISSUE OCCURRED DURING MAINTENANCE OF THE SUBJECT DEVICE AT CUSTOMER SITE. THERE WAS NO PROCEDURE INVOLVED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17990923 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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