GreenLight XPS™ 0010-0210S-GZ0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729979173), received between Sep 5, 2023 and Apr 23, 2026 — classified as 6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Nonstandard Device; Failure to Power Up; Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE DISPLAYED ERROR CODE 213 (LASER POWER SUPPLY OFF SETPOINT) AFTER 30 MINUTES OF USE. WHEN "CLEAR PROBLEM" WAS PRESSED, THE POWER SHUT OFF AND THE CONSOLE WOULD NOT START UP AFTERWARD. RESTARTING FROM THE BREAKER DID NOT CHANGE THE SITUATION. THERE WAS A SLIGHT UNUSUAL ODOR WAS ALSO NOTED. THE PROCEDURE WAS COMPLETE USING A NON BSC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND SERVICED THE CONSOLE AT THE FACILITY. DURING EVALUATION OF THE CONSOLE, A BURNING SMELL WAS DETECTED; THEREFORE, REPORTABILITY CRITERIA IS MET BASED ON THIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974810 ↗
• MalfunctionMar 16, 2026Power Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE DISPLAYED ERRORS 211 (LASER POWER SUPPLY BRICK FAULT) AND 213 (LPS OFF SETPOINT). THE CONSOLE POWERED OFF AND DID NOT TURN POWER ON AGAIN. DUE TO THIS, THE PROCEDURE COULD NOT BE COMPLETED WHEN THE PATIENT WAS UNDER GENERAL SEDATION. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614113 ↗
• MalfunctionJun 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PREPARATION PRIOR TO PROCEDURE, THE COAGULATION PEDAL REMAINED ACTIVATED, IT APPEARS THAT THE CONTACT IS DAMAGED. THE PROCEDURE WAS COMPLETED USING THE SAME GENERATOR WITH A DIFFERENT FOOT SWITCH WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308263 ↗
• MalfunctionMay 15, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERROR CODE 660 DURING PROCEDURE. THE CONSOLE WAS TURNED OFF FOR SAFETY AND THEN ERROR CODED 611 AND 831 WERE DISPLAYED, THEREFORE, THE DAY WAS SUSPENDED. THERE WAS NO PROCEDURE AND PATIENT OUTCOME REPORTED. A FULL SERVICE WAS PERFORMED ON THE CONSOLE; HOWEVER NO ISSUES WERE OBSERVED DURING THE EVALUATION. ALSO, WAS INFORMED THAT THE CITY WHERE THE EQUIPMENT IS LOCATED HAS BEEN EXPERIENCING ISSUES WITH THE ELECTRICAL GRID, AND THAT ELECTRICAL IRREGULARITIES MAY BE CONTRIBUTING TO THE REPORTED ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032100 ↗
• MalfunctionMar 26, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING PREPARATION FOR THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE SCREEN DID NOT DISPLAY ANY IMAGES. THE PROCEDURE WAS THEN CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981212 ↗
• MalfunctionSep 5, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROSTATE ABLATION PROCEDURE, THE CONSOLE LAUNCHES AN EMERGENCY SHUTDOWN MESSAGE, AND THE PROCEDURE COULD NOT BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687544 ↗