GreenLight XPS 0010-0210HRecalls & 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
- 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 00878953001890), received between Mar 27, 2023 and Mar 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 18, 2026.
Most reported problems
Device problems
- Device Displays Incorrect Message1
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.
MalfunctionMar 27, 2023Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE, THE FIBER WAS NOT RECOGNIZED BY THE CONSOLE. THE CONSOLE WAS TRIED WITH ANOTHER FIBER AND ERROR CODE 521 (LANGUAGE INITIALIZATION FAILED) OCCURRED. THE CONSOLE STOPPED WORKING. THERE WERE NO PATIENT COMPLICATIONS; HOWEVER, THE PROCEDURE WAS NOT COMPLETED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619392 ↗
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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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