GreenLight XPSRecalls & reported problems across all models
American Medical Systems · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 207
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 0
We found 5 models of GreenLight XPS by American Medical Systems in the FDA's device registry (GUDID). Together they are named in 207 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2018 and Sep 28, 2026 — classified as 37 injuries, 170 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (62 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GreenLight XPS problems
Device problems
- Device Displays Incorrect Message62
- Adverse Event Without Identified Device or Use Problem46
- Smoking41
- Physical Resistance/Sticking30
- Defective Device22
- Power Problem14
- Communication or Transmission Problem8
- Failure to Power Up8
Patient problems
- No Clinical Signs, Symptoms or Conditions150
- No Consequences Or Impact To Patient48
- No Known Impact Or Consequence To Patient11
- No Patient Involvement4
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- Fever1
- Insufficient Information1
GreenLight XPS models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GreenLight XPS 0010-0210Powered Laser Surgical Instrument153 reports
- GreenLight XPS 0010-0210RPowered Laser Surgical Instrument49 reports
- GreenLight XPS 0010-0210ZPowered Laser Surgical Instrument3 reports
- GreenLight XPS 0010-0210HPowered Laser Surgical Instrument1 report
- GreenLight XPS 0010-0210DPowered Laser Surgical Instrument1 report
Recent GreenLight XPS adverse event reports
The 15 most recent reports across all models, 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 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 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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