GreenLight XPS 0010-0210Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00878953005508), received between Jun 29, 2018 and Sep 24, 2026 — classified as 29 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (43 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Power Conditioning Problem; Unexpected Shutdown

  It was reported that during a procedure the laser shut off twice in the middle of a case. It was found the breaker was tripped, it was repaired, the breaker was on, but it powered down again. The procedure was not completed due to the power issue. There was no patient complication.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 50883915 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported that prior to procedure, the device's foot pedal was not responsive. The procedure was not completed due to this event. There were no patient complications. This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803380 ↗
• MalfunctionSep 16, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794315 ↗
• MalfunctionApr 22, 2026Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT, THE FOOTSWITCH WAS NOT FUNCTIONING PROPERLY. THERE WAS CORROSION ON BOTH PEDALS OF THE FOOTSWITCH. THIS CAUSES THE PEDALS TO STAY DEPRESSED EVEN AFTER REMOVING THE FOOT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955503 ↗
• MalfunctionApr 9, 2026Infusion or Flow Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONSOLE HAS A BROKEN WATER RESERVOIR. THE PLASTIC CONNECTOR IS ALSO SHEARED OFF. DUE TO THIS, THE PROCEDURE HAD TO BE CANCELLED. 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 24834982 ↗
• MalfunctionNov 19, 2025Communication or Transmission Problem; Power Problem; Communication or Transmission Problem; Power Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, ERRORS 171 (UNDER POWER), 235 (NO LPS CURRENT), 202.11 (LPS HARDWARE INTERLOCK, INTERLOCK OPEN) AND 102.9 (RCB HARDWARE INTERLOCK BIT, PD0 OVER POWER) WERE DISPLAYED. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596431 ↗
• MalfunctionNov 13, 2025Failure to Power Up; Smoking; Failure to Power Up; Smoking

  IT WAS REPORTED THAT BIOMED, STATED THE UNIT WOULD NOT POWER ON. THE CONSOLE WAS BROUGHT TO BIOMED AFTER PRODUCING A BURNING SMELL; HOWEVER, WHEN ATTEMPTING TO POWER IT BACK ON, IT FAILED TO START AND ERROR CODES COULD NOT BE CONFIRMED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547276 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE THE FOOT PEDAL BEGAN STICKING AND STOP WORKING. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296191 ↗
• MalfunctionSep 22, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT LASER CONSOLE STOPPED IN THE MIDDLE OF THE PROCEDURE, AND IT DOES NOT START. THIS PROCEDURE WAS NOT COMPLETED WITH A PATIENT UNDER EPIDURAL ANESTHESIA. THE CASE WAS RE-SCHEDULED AND THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER EPIDURAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23112490 ↗
• MalfunctionAug 5, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE PROMPTED AN ERROR CODE 302.8 (MCB HARDWARE INTERLOCK BIT) AND ERROR CODE 202.11 (LPS HARDWARE INTERLOCK.) THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722641 ↗
• MalfunctionJul 24, 2025Smoking; Defective Device; Device Displays Incorrect Message; Smoking; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING THE PREVENTATIVE MAINTENANCE, THE FUSE BLEW. ADDITIONAL INFORMATION RECEIVED INFORMED THAT THE MACHINE SCREEN WENT WHITE WITH A GOODBY MESSAGE AND THERE WAS A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592486 ↗
• MalfunctionJul 2, 2025Smoking; Defective Device; Device Displays Incorrect Message; Noise, Audible; Smoking; Defective Device; Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE SHUT DOWN AFTER DISPLAYING A GOODBYE MESSAGE. A BLOWN FUSE WAS FOUND IN THE DIODE POWER SUPPLY; THEREFORE, IT WAS REPLACED. BEFORE RECONNECTING THE CONSOLE, IT WAS NOTICED SOME SPARKS FROM THE MAINS PLUG, DISCOVERED A LOOSE LIVE WIRE, AND REPLACED THE PLUG. WHEN TURNING THE UNIT BACK ON, THERE WAS A POPPING SOUND AND SMOKE FROM THE REAR BOTTOM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386739 ↗
• MalfunctionJun 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE CONSOLE DISPLAYED ERRORS 302.13 (FIBER NOT PRESENT), 611 (CHILLER PROCESS FAULT), 660 (CHILLER TEMP. FAULT) AND 831 (INTERLOCK DURING WARMUP) AFTER 80 KILOJOULES WERE EXPENDED. THERE WERE NO PATIENT CONSEQUENCES; HOWEVER, THE PATIENT WAS SEDATED, AND THE PROCEDURE HAD TO BE CANCELLED. 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 22299014 ↗
• MalfunctionMay 23, 2025Smoking; Device Displays Incorrect Message; Noise, Audible; Smoking; Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT DURING MID PROCEDURE, THE CONSOLE MADE A VERY LOUD BANG AND BURNING SMELL WAS NOTED. THE CONSOLE DISPLAYED ERROR E235 (NO LPS CURRENT). BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080686 ↗
• MalfunctionMay 19, 2025Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem; Power Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE LASER UNIT DISPLAYED ERROR E821 AND ERROR: 211 (LASER POWER SUPPLY BRICK FAULT) FOLLOWED BY ERROR 202.2 (E202 LPS HARDWARE INTERLOCK). THE PROCEDURE WAS CANCELLED. 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 22043305 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE 112TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION JOURNAL, A PAPER WAS PRESENTED WITH THE OBJECTIVE OF STUDYING THE EFFICACY AND SAFETY OF THE PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE FOR TREATING BENIGN PROSTATIC HYPERPLASIA (BPH) IN PATIENTS WITH A PROSTATIC VOLUME GREATER THAN 80 ML. THE STUDY INCLUDED 151 PATIENTS WHO UNDERWENT PVP PROCEDURES USING A GREENLIGHT CONSOLE BETWEEN JULY 2019 AND AUGUST 2023. AMONG THEM, 35 PATIENTS WITH A PROSTATE VOLUME OF 80 ML OR MORE WERE INCLUDED FOR COMPARISON. THE STUDY EVALUATED IPSS, QOL INDEX, URODYNAMIC PARAMETERS, CHANGES IN RESIDUAL URINE VOLUME, AND SAFETY OUTCOMES. IN THE GROUP OF 35 PATIENTS, FEBRILE URINARY TRACT INFECTIONS WERE OBSERVED IN 6 PATIENTS, POSTERIOR HEMORRHAGE REQUIRING TU-EC (TRANSURETHRAL ELECTROCOAGULATION) OCCURRED IN ONE PATIENT, AND ONE PATIENT REQUIRED REVISION SURGERY. NO ADVERSE EVENTS WERE MENTIONED REGARDING THE GROUP OF PATIENTS WITH A PROSTATE VOLUME WITH LESS THAN 80 ML.

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 22037744 ↗
• MalfunctionMay 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SYSTEM DUE TO DURING SURGERY THE GREEN LIGHT WAS FLASHING YELLOW, AND IT HAS CAUSED THE CANCELATION OF A NUMBER OF SURGERIES. NO FURTHER INFORMATION WAS PROVIDED. 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 21968278 ↗
• MalfunctionMay 1, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PREVENTIVE MAINTENANCE, IT WAS FOUND SMOKE COMING OUT FROM THE SELECTOR BOARD, BELOW THE CHILLER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944361 ↗
• MalfunctionApr 9, 2025Smoking; Unexpected Shutdown; Smoking; Unexpected Shutdown

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE HAD AN UNEXPECTED SHUTDOWN AND A SHORT-CIRCUIT SMELL WAS DETECTED. IT WAS ALSO NOTED THAT AN ATTEMPT TO RESTART THE DEVICE WAS UNSUCCESSFUL AND TESTING IT IN A DIFFERENT OUTLET ALSO FAILED TO TURN IT ON. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809109 ↗
• MalfunctionFeb 25, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT, THERE WAS A CLICKING NOISE DURING TREATMENT. 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 21463331 ↗
• MalfunctionFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER USING THE FOOT PEDAL THE UNIT CONTINUED TO FIRE. THE CUSTOMER IS REQUESTING THAT THE LASER CONSOLE AND FOOT PEDAL ARE CHECKED. THERE WERE NO ERROR MESSAGES REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428924 ↗
• MalfunctionDec 11, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT PRIOR TO PROCEDURE THE CONSOLE DISPLAY SCREEN WENT WHITE AFTER PLUGGING IN THE FIBER. IT WAS TURNED OFF, REMOVED FIBER, TURNED BACK ON, PLUGGED IN THE FIBER, STILL GOT THE WHITE SCREEN. BIOMED CHECKED ON THE LASER AFTER, TURNED ON THE LASER, WITH THE FIBER REMOVED AND THE SCREEN WAS WHITE STILL. THE PATIENT WAS UNDER GENERAL ANESTHESIA, STAFF WOKE UP THE PATIENT IN STABLE CONDITION, NO INJURY FOR PATIENT BUT THE PROCEDURE HAD TO BE CANCELED DUE TO THIS EVENT. 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 20906086 ↗
• MalfunctionNov 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FOOT PEDAL STICKING AND IT NEEDS A REPLACEMENT. THERE WAS NO PROCEDURE AND PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803706 ↗
• MalfunctionOct 29, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, ERROR 832 (INT 0 TEST FAILED) AND 302 (MCB HARDWARE INTERLOCK BIT) WERE DISPLAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ERROR CODE. THERE WAS NO PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561789 ↗
• MalfunctionOct 23, 2024Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519151 ↗