GreenLight XPS 0010-0210ZRecalls & reported problems
American Medical Systems · Laser System · Class 2
All models of GreenLight XPS (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878953001913), received between Jul 26, 2021 and Sep 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.
Reports received per month
Most reported problems
Device problems
- Device Displays Incorrect Message2
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2025Smoking; Smoking
IT WAS REPORTED THAT DURING CAPITAL EQUIPMENT INSTALLATION, THE DEVICE'S SCREEN BEGAN TO EMIT FIRE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084293 ↗MalfunctionApr 8, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING THE PHOTOVAPORIZATION OF THE PROSTATE PROCEDURE, ERRORS 171 AND 820 DISPLAYED. DUE TO THIS, THE PROCEDURE COULD NOT BE COMPLETED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21802368 ↗MalfunctionJul 26, 2021Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING PREPARATION FOR A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, ERROR 171 OCCURRED. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT COMPLICATION RELATED TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR PROCEDURE/POST SEDATION AND WHERE THE PROCEDURE WAS CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12224515 ↗
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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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