VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200 (UDI 04953170386022)Recalls & reported problems
Olympus Medical Systems Corp. · VISERA ELITE II VIDEO SYSTEM CENTER · Class 2
All models of VISERA ELITE II VIDEO SYSTEM CENTER (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus VISERA ELITE II video system center is an imaging unit used with endoscopes. Many of the 860 reports describe no display or image, communication errors with connected scopes and failure to power up, and some describe a camera connection problem that led to a procedure being completed with a back-up device. The reports include 3 injuries and no 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
- 870
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 870 adverse event reports that list this exact device (DI 04953170386022), received between Dec 30, 2020 and Sep 29, 2026 — classified as 3 injuries, 867 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (242 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
Most reported problems
Device problems
- No Display/Image242
- Communication or Transmission Problem236
- Output Problem100
- Display or Visual Feedback Problem43
- Failure to Power Up35
- Electrical /Electronic Property Problem31
- Poor Quality Image31
- Erratic or Intermittent Display28
Patient problems
- No Clinical Signs, Symptoms or Conditions862
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Electric Shock2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 870 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934172 ↗MalfunctionSep 23, 2026Naturally Worn; Data Problem
The customer reported the video system center had stopped working in the middle of an unspecified procedure. The procedure was completed using a back-up device. No patient harm was reported. During the initial evaluation of the returned device, the reported event was confirmed and related to the internal buffer being full. Also, a worn-out light guide slider switch was found to have caused an intermittent high intensity mode.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863173 ↗MalfunctionSep 18, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831149 ↗MalfunctionSep 18, 2026Communication or Transmission Problem
The customer reported an error message that stated to clean the electrical panels during an unspecified procedure involving an Olympus Video System Center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817923 ↗MalfunctionSep 18, 2026Communication or Transmission Problem
The customer reported error code E226 during an unspecified procedure with the Olympus Video System Center. No patient injuries occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817554 ↗MalfunctionSep 17, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809911 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem
The customer reported that the light was dim despite being adjusted to the maximum level in both auto and manual modes on an Olympus Video System Center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790502 ↗MalfunctionSep 15, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780766 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
The customer reported an error code E333 during Diagnostic Laryngoscopy completed with the same device involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773860 ↗MalfunctionSep 11, 2026No Device Output
The customer reported that the device was not functioning during maintenance involving an Olympus Video System Center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738537 ↗MalfunctionSep 11, 2026Unexpected Mode Switch
The customer reported it intermittently entering standby mode including inadvertent button activation during ureteroscopy involving an Olympus video system center. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731930 ↗MalfunctionSep 11, 2026Poor Quality Image
It was reported that the video system center had red lines running through the image. The issue was found during an unspecified diagnostic procedure that was completed using a fiberscope with light source. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726547 ↗MalfunctionSep 10, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715354 ↗MalfunctionSep 10, 2026Electrical /Electronic Property Problem
The customer reported Inadvertent button activation and Intermittent standby activation during a ureteroscopy procedure involving an Olympus videoprocessor. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713517 ↗MalfunctionSep 2, 2026Activation Failure
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567303 ↗MalfunctionAug 27, 2026Communication or Transmission Problem
The customer reported the Video system center had E226 Scope communication error during sedation of a diagnostic ureteroscopy procedure while the device was inside the patient. The procedure was completed with an Olympus back up device. During the initial evaluation of the device, it was observed loose light guide socket, no image and low brightness. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483745 ↗MalfunctionAug 25, 2026Communication or Transmission Problem
The customer reported bulb error during an inspection for use involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50423055 ↗MalfunctionAug 12, 2026Communication or Transmission Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224322 ↗MalfunctionAug 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192034 ↗MalfunctionAug 7, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175332 ↗MalfunctionAug 6, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160985 ↗MalfunctionAug 5, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147463 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146394 ↗MalfunctionAug 5, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144216 ↗MalfunctionAug 4, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131213 ↗
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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 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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