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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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