GreenLight XPS 0010-0210RRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00878953001906), received between Nov 20, 2018 and Sep 28, 2026 — classified as 8 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (15 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Communication or Transmission Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923706 ↗
• MalfunctionSep 28, 2026Insufficient Cooling; Communication or Transmission Problem; Power Problem

  It was reported that during procedure, the device displayed error codes 641 (Chiller Serial Not Set), 302-13 (Fiber Not Present) and 202-11 (Interlock Open). The device was unable to be used for the procedure and the procedure was stopped. There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or whose sedation status is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915299 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem; Power Problem

  It was reported that during a photoselective vaporization of the prostate, the console displayed error 213 (LPS Off Setpoint), 235 (No LPS Current), 202.11 (LPS Hardware Interlock - Interlock Open), and 302.13 (MCB Hardware Interlock Bit - Fiber Not Present). The procedure was not completed. There were no patient complications.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 50871156 ↗
• MalfunctionJul 16, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS A FOOT PEDAL MALFUNCTION AS IT KEEPS STUCK ON ONE POSITION. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849868 ↗
• MalfunctionJul 9, 2026Communication or Transmission Problem; Material Integrity Problem; Power Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE DISPLAYED ERROR CODES 831 (INTERLOCK DURING WARMUP), 302.13 (MCB HARDWARE INTERLOCK BIT), 102.9 (RCB HARDWARE INTERLOCK BIT), AND 235 (NO LPS CURRENT). THE PROCEDURE WAS CANCELED. THERE WAS NO PATIENT IMPACT, AS THE PROCEDURE HAD NOT BEEN INITIATED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25767012 ↗
• MalfunctionMay 13, 2026Smoking; Communication or Transmission Problem; Complete Loss of Power

  IT WAS REPORTED THAT BY THE END OF PROCEDURE, THE LASER HAD BURNING SMELL COMING OUT OF IT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS. FURTHER INVESTIGATION REVEALED THAT THE DEVICE DISPLAYED ERROR CODE 852 (SHUTDOWN FAILED) AND DID NOT HAVE POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157543 ↗
• MalfunctionMar 23, 2026Failure to Power Up; Smoking; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A CASE, THE DEVICE POWERED DOWN SUDDENLY AND WILL NOT POWER ON ANYMORE. IT WAS ALSO OBSERVED THAT A LARGE CAPACITOR BEGAN TO SMOKE. NO INFORMATION REGARDING THE PATIENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665073 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Device Displays Incorrect Message; Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED A FIBER PORT OVERHEATED ERROR MESSAGE WHEN THE FIBER REACHED AROUND 10,000 JOULES. IN ADDITION, IT WAS NOTED THAT THERE WERE NO PHYSICAL DAMAGES OBSERVED ON THE CONSOLE, HOWEVER IT WAS NOT WORKING AS IT SHOULD. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER THE PATIENT WAS UNDER ANESTHESIA WHEN THE CONSOLE ERROR MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT AND PROCEDURE OUTCOME REPORTED. 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 23612739 ↗
• MalfunctionFeb 5, 2025Smoking; Smoking

  IT WAS REPORTED THAT CONSOLE SUDDENLY TURNED OFF AND WOULD NOT START. ADDITIONALLY, A BURNING SMELL WAS NOTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315418 ↗
• MalfunctionNov 27, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR CODE 652 (THE CHILLER DID NOT SENSE FLOW AFTER THE TIMEOUT PERIOD) OCCURRED DURING A PHOTO-SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS; HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED. 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 20790742 ↗
• MalfunctionApr 24, 2024Fluid/Blood Leak; Smoking; Fluid/Blood Leak; Smoking

  IT WAS REPORTED THAT WHEN THE NURSE WAS ADDING WATER TO THE LASER CONSOLE, THE WATER BEGAN TO LEAK, AND SMOKE BEGAN TO COME OUT OF THE SYSTEM. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176647 ↗
• MalfunctionMar 7, 2024Smoking; Defective Device; Device Displays Incorrect Message; Smoking; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE DISPLAYED ERROR 211 AND 213. THE CONSOLE WAS RESTARTED, HOWEVER, ERROR 521 THEN DISPLAYED AND A SMELL OF SMOKE WAS REPORTED. THE BIOTECH ENGINEER ATTEMPTED TO RESTART THE CONSOLE TO TROUBLESHOOT HOWEVER, THE CONSOLE SYSTEM DID NOT WORK PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862112 ↗
• MalfunctionJan 25, 2024Smoking; Material Integrity Problem; Smoking; Material Integrity Problem

  IT WAS REPORTED THAT THE DISPLAY CABLE WAS BURNED. THE ISSUE HAS BEEN NOTICED WHEN THE DEVICE WAS TURNED ON. THE DISPLAY WENT BLACK (BLACK SCREEN), AND A BURNING SMELL WAS NOTICED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582135 ↗
• MalfunctionJan 24, 2024Smoking; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Smoking; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SCREEN WENT BLACK DURING USE, AND A BURNING SMELL WAS NOTICED. 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 18575238 ↗
• MalfunctionNov 29, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION IT WAS NOTICED THAT THE FOOTSWITCH DOES NOT WORK ANYMORE AND HAS AN EXPOSED WIRE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED WITH THE PATIENT ALREADY UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229867 ↗
• MalfunctionOct 5, 2023Defective Device; Device Displays Incorrect Message; Power Problem; Defective Device; Device Displays Incorrect Message; Power Problem

  IT WAS REPORTED THAT DURING A TREATMENT, THE CONSOLE DISPLAYED ERROR 509 AND THE ERROR WAS CLEARED AFTER TURNING OFF AND RE-PLUGGING THE DEVICE. WHEN THE CONSOLE TURNED ON AGAIN, IT PRESENTED AN UNKNOWN POWER RELATED DIFFICULTY. DUE TO THIS, 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 17878049 ↗
• MalfunctionApr 18, 2023Smoking; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Smoking; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE APPOINTMENT, THE FIELD SERVICE ENGINEER (FSE) SMELT AND SAW SMOKE COMING FROM THE CONSOLE. SOON AFTER, ERROR CODES 154 AND 102.5 WERE RECEIVED. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765417 ↗
• MalfunctionJul 12, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GIVEN GENERAL ANESTHESIA PRIOR TO A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE. DURING THE PROCEDURE AN ERROR MESSAGE WAS RECEIVED STATING THE FIBER PORT OVERHEATED. THE FIBER WAS REPLACED, BUT THE ERROR MESSAGE APPEARED WITH THE SECOND FIBER ALSO. THE PROCEDURE WAS THEN RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989158 ↗
• MalfunctionJun 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ASSY REFILL BOTTLE F FITTING IS EMPTY. 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 UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838817 ↗
• MalfunctionJun 16, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR 302.13 AND 832 WERE RECEIVED ON THE CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT AND THE PATIENT HAD BEEN SEDATED WITH GENERAL ANESTHESIA AT THE TIME. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14723856 ↗
• MalfunctionJun 8, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERROR CODES 630, 302.13, 102.3, 202.11 AND 710. A PROBLEM WITH THE CHILLER WAS SUSPECTED. IT WAS INDICATED THAT THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. 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 14631195 ↗
• MalfunctionJun 7, 2022Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONSOLE YELLOW AND BLUE PEDALS LOCKED AFTER BEING PRESSING. THE PEDAL WAS VERY OXIDIZE DUE TO AGING. A TEMPORARY REPAIR WAS MADE TO COMPLETE THE PROCEDURE WITH THIS CONSOLE WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. A NEW PEDAL WAS SUBSEQUENTLY INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626940 ↗
• MalfunctionMay 31, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT WHEN STARTING UP THE CONSOLE, THE SCREEN DISPLAYED A GOODBYE MESSAGE. TROUBLESHOOTING WAS ATTEMPTED BY REBOOTING THE CONSOLE; HOWEVER, THE MESSAGE PERSISTED. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT; HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. 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 14550766 ↗
• MalfunctionApr 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PHOTO-SELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE FOOTSWITCH IS BECOMING STUCK. THE FOOTSWITCH CONTACT DOES NOT APPEAR TO BE CORRECT. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14150067 ↗
• MalfunctionMar 24, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE UNIT IS DISPLAYING ERROR MESSAGE FOR FIBER TYPE DOES NOT MATCH CARD TYPE. THE CUSTOMER CONFIRMED BOTH THE FIBER AND THE CARD WERE MOXY, BUT THE FIBER GETS STUCK IN THE UNIT AND WILL NOT DISCONNECT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE (MAC) SEDATION WHEN THE PROCEDURE WAS CANCELLED. AFTER THE PROCEDURE WAS CANCELLED, THE MEDICAL STAFF SUCCESSFULLY UNPLUGGED THE FIBER FROM THE CONSOLE AND THE UNIT IS WORKING AS INTENDED. THERE WERE NO PATIENT COMPLICATIONS. THIS REPORT IS BEING SUBMITTED DUE TO THE ABORTED/CANCELLED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873086 ↗