Disposable Pneumatic Vitrectome, 25 Gauge/0.5 mm working with 37 PSI, max2500 c 2267.NMD05Recalls & reported problems
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717872017297), received between Feb 6, 2018 and Feb 7, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (2 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.
Most reported problems
Device problems
- Device Operational Issue2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED FROM A FACILITY LOCATED IN (B)(6). THE FOLLOWING WAS REPORTED "AIR BUBBLES". THERE IS NO FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7248624 ↗MalfunctionFeb 6, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED OF AN EVENT OCCURRING IN (B)(6). IT WAS REPORTED AIR BUBBLE. THERE IS NO FURTHER INFORMATION ON THIS INCIDENT. NO SAMPLE WAS SAVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7245642 ↗
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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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