ORBEYE SURGICAL MICROSCOPE OME-V200Recalls & reported problems
Olympus Medical Systems Corp. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170395871), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
THE CUSTOMER REPORTED THAT THE IMAGE WAS FLASHING DURING AN IGG USAGE RELATED TO THE OME-V200-U W/POWER CORD. THERE WAS NO IMAGE LOSS HOWEVER, AN OBSERVATION OF A FLASHING IN THE UPPER RIGHT CORNER OF THE IMAGE WAS SEEN. THE EVENT OCCURRED DURING PROCEDURE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287727 ↗
Other MICROSCOPE, SURGICAL devices
- M530 Optics Carrier 000000000010448704Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL4 reports
- M530 OHX 000000000010448737Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- PROvido 000000000010448950Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- IMAGE1 PILOT TC014Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL2 reports
- M525 F20 000000000010448284Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- PROvido 000000000010448976Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- 1788 1788210080Stryker Corporation · Microscope, surgical1 report
- ARveo 000000000010448999Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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