GreenLight XPS™ 0010-0210S-G0Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729979135), received between Jun 7, 2023 and Sep 18, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828847 ↗
• MalfunctionDec 12, 2025Smoking; Power Problem; Unexpected Shutdown; Smoking; Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE SHUTDOWN AND THE ERROR CODES 210-LASER POWER SUPPLY AND 211-LASER POWER SUPPLY BRICK FAULT WERE DISPLAYED. AFTER SHUTTING DOWN, IT DID NOT START EVEN WHEN THE POWER WAS TURNED BACK ON. WHEN THE POWER CORD WAS UNPLUGGED AND LEFT FOR A WHILE BEFORE RESTARTING, SMOKE WAS EMITTED, POSSIBLY DUE TO SOMETHING BURNING INSIDE. THE PROCEDURE WAS COMPLETED WITH TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791133 ↗
• MalfunctionSep 22, 2025No Display/Image; Smoking; No Display/Image; Smoking

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE LASER WAS POWERED ON, THE DISPLAY SCREEN WAS BLACK AND BURNING SMELL WAS COMING OUT OF LASER. ANOTHER DEVICE OF DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110948 ↗
• MalfunctionJun 6, 2025Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Defective Device; Device Displays Incorrect Message; Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT PRIOR THE PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE IS STUCK DISPLAYING, PLEASE WAIT. IT WAS NOTED THE CONSOLE DISPLAYED ERROR 302.13 (MCB. HARDWARE INTERLOCK BIT) AND ERROR 632 (WARMUP TIMEOUT). THE PROCEDURE WAS DISCONTINUED. 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 22160067 ↗
• MalfunctionMar 19, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PHOTO SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, THE CONSOLE DID NOT PROCEED FROM PLEASE WAIT, THEREFORE, THE DEVICE COULD NOT BE USED. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO REPORTED ISSUE. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646740 ↗
• MalfunctionFeb 25, 2025Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE DOES NOT START UP, AND ERRORS 630, 302.13, 202.11 AND 710 DISPLAYED. THE ERRORS CLEARED, BUT ERROR 630 SHOWED AGAIN. THE CONSOLE WAS RESTARTED AFTER REFILLING PURIFIED WATER, BUT THE PROBLEM PERSISTED. 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 21458199 ↗
• MalfunctionAug 1, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DISPLAYED ERROR CODES 211, 213 AND 825. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19888188 ↗
• MalfunctionJul 10, 2024Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Use of Device Problem; Device Displays Incorrect Message; Power Problem; Insufficient Cooling; Electrical /Electronic Property Problem; Nonstandard Device; Use of Device Problem; Device Displays Incorrect Message; Power Problem

  IT WAS REPORTED THAT PRIOR TO A PHOTO SELECTIVE VAPORIZATION PROCEDURE FOR BLADDER STONE, THE CONSOLE WAS STARTED, BUT THEN THE DEVICE WAS TURNED OFF IN ORDER TO SWITCH THE POWER SUPPLY. AFTER THAT THE CONSOLE DID NOT START UP AND IT DISPLAYED ERROR CODES 641, 302.13, AND 202.11. THE CONSOLE WAS REBOOTED, BUT THE ERROR CODES DID NOT CLEAR. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, THE PROCEDURE WAS CANCELLED. 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 19711205 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE 111TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION JOURNAL THAT A STUDY WAS CONDUCTED TO EXAMINE THE EFFECTIVENESS AND SAFETY OF PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE AFTER EXPERIENCING 100 CASES SINCE ITS INTRODUCTION. BETWEEN JULY 2022 TO AUGUST 2023, A TOTAL OF 100 PATIENTS DIAGNOSED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) WERE INCLUDED IN THIS STUDY. FIVE PATIENTS HAD A HISTORY OF URINARY RETENTION, AND FOUR OF THEM HAD AN INDWELLING URINARY CATHETER OR SELF-CATHETERIZED AT THE TIME OF SURGERY. IT WAS OBSERVED THAT THERE WAS POSTOPERATIVE SERUM HEMOGLOBIN CONCENTRATION DECREASE. THERE WERE TWO CASES OF REOPERATION FOR BLADDER NECK SCLEROSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 19702664 ↗
• MalfunctionMay 21, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT PRIOR TO A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, A MESSAGE INDICATING THE FIBER EXPIRED WAS DISPLAYED. THE FIBER WAS CHANGED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED OR RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS. IT WAS NOTED THAT THE TECHNICIAN WENT ONSITE AFTERWARDS, AND FOUND IT IS NORMAL FOR THE MACHINE TO TIME OUT AFTER 30 MINUTES OF INACTIVITY. THIS EVENT IS BEING REPORTED FOR CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356554 ↗
• MalfunctionMar 1, 2024Poor Quality Image; Device Displays Incorrect Message; Poor Quality Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT, IN PREPARATION FOR THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE PATIENT HAD BEEN GIVEN GENERAL ANESTHESIA. WHILE PREPARING FOR THE PROCEDURE, ERROR 521 (LANGUAGE INITIALIZATION FAILED) OCCURRED WHEN THE CONSOLE WAS STARTED UP. ADDITIONALLY, THE LETTERS ON THE MONITOR WERE DISPLAYED SIDEWAYS. THE CONSOLE AND BREAKER WERE TURNED OFF, THE CUSTOMER WAITED 30 SECONDS, AND THEN THE CONSOLE WAS RESTARTED. ERROR 521 NO LONGER APPEARED. HOWEVER, THE LETTERS ON THE CONSOLE SCREEN WERE STILL DISPLAYED SIDEWAYS. THE CONSOLE WAS TURNED OF AND ON MULTIPLE TIMES BUT THE ISSUE DID NOT RESOLVE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817486 ↗
• MalfunctionSep 25, 2023Failure to Power Up; Smoking; Device Displays Incorrect Message; Failure to Power Up; Smoking; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE PROMPTED ERROR CODES 211, 213, AND 302.13. THE CONSOLE IS NO LONGER POWERING ON AND IS SMOKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONSOLE AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813661 ↗
• MalfunctionAug 21, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE START OF A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE THE FIBER PORT OVERHEATED. ANOTHER FIBER WAS TRIED WITH THE SAME RESULTS, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. 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 17592458 ↗
• MalfunctionJun 16, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE PATIENT WAS ALREADY SEDATED, THERE WAS A FIBER CONNECTION ERROR THAT OCCURRED. THE FIBER WAS REPLACED AND THE UNIT RESTARTED BUT IT DID NOT RESOLVE THE PROBLEM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ISSUE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145409 ↗
• MalfunctionJun 7, 2023Smoking; Noise, Audible; Unintended Application Program Shut Down; Smoking; Noise, Audible; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING PROCEDURE THIS CONSOLE SHUT DOWN AFTER HEARING THE SOUND OF BURNING INSIDE THE MACHINE. AFTER INSPECTING, BURN MARKS WERE FOUND INSIDE THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONSOLE AND ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083883 ↗