VersaPulse PowerSuiteRecalls & reported problems across all models
Lumenis Ltd. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 125
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of VersaPulse PowerSuite by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 125 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2022 and Sep 30, 2026 — classified as 1 injury, 124 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (69 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 VersaPulse PowerSuite problems
Device problems
- Output below Specifications69
- Device Displays Incorrect Message20
- Smoking15
- Defective Device14
- Adverse Event Without Identified Device or Use Problem12
- Nonstandard Device11
- Unintended Application Program Shut Down9
- Appropriate Device Problem Term/Code Not Available6
Patient problems
- No Clinical Signs, Symptoms or Conditions125
- Respiratory Insufficiency1
VersaPulse PowerSuite models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VersaPulse PowerSuite VersaPulse PowerSuite 100WPowered Laser Surgical Instrument64 reports
- VersaPulse PowerSuite VersaPulse PowerSuite 100WPowered Laser Surgical Instrument24 reports
- VersaPulse PowerSuite VersaPulse PowerSuite 100WPowered Laser Surgical Instrument11 reports
- VersaPulse PowerSuite VersaPulse PowerSuite 60WPowered Laser Surgical Instrument10 reports
- VersaPulse Powersuite VersaPulse Powersuite 80/100WPowered Laser Surgical Instrument9 reports
- VersaPulse PowerSuite VersaPulse PowerSuite 80/100WPowered Laser Surgical Instrument5 reports
- VersaPulse PowerSuite VersaPulse PowerSuite 100WPowered Laser Surgical Instrument2 reports
Recent VersaPulse PowerSuite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Output below Specifications
It was reported that during preparation, the device prompted Low energy message. There was no patient or procedure involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952410 ↗MalfunctionSep 29, 2026Output below Specifications
It was reported that the console had low energy. There was no error code message. There is no information whether a procedure was performed, or if there was patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927867 ↗MalfunctionSep 21, 2026Communication or Transmission Problem; Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847391 ↗MalfunctionSep 17, 2026Smoking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812534 ↗MalfunctionSep 17, 2026Material Integrity Problem; Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809748 ↗MalfunctionAug 14, 2026Output below Specifications
It was reported that the power was reduced. 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 50245619 ↗MalfunctionJul 21, 2026Communication or Transmission Problem
It was reported that during preparation prior to a procedure, when booting up the console to test fire, an error message appeared stating " "Maximum available Ho:Yag pulse rate reduced to 10Hz" and "Maximum available Ho:Yag power reduced to 20W". The technician restarted the console but error All lasers are malfunctioning, please call Coherent Service" appeared. There were no patient complications, the case had to be cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25897145 ↗MalfunctionMay 14, 2026Output below Specifications
IT WAS REPORTED THAT THE DEVICE EXHIBITED LOW OUTPUT POWER. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167753 ↗MalfunctionMay 13, 2026Fluid/Blood Leak; Output below Specifications
IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE EXPERIENCED A LOW ENERGY MALFUNCTION AS THE ENERGY WAS OVER 50 PERCENT LOWER THAN REQUESTED. NO COURTESY MESSAGE WAS DISPLAYED, AND COOLANT LEAKAGE WAS OBSERVED FROM THE SECOND CAVITY. NO PATIENT INVOLVED. ADDITIONALLY, DURING THE HOLEP SURGERY, THE PHYSICIAN COMPLAINED THAT THE TISSUE WAS NOT CUTTING PROPERLY USING THE STANDARD SETTINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157536 ↗MalfunctionApr 30, 2026Output below Specifications
IT WAS REPORTED THAT THE CONSOLE WAS NOT PROVIDING FULL POWER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048024 ↗MalfunctionApr 16, 2026Output below Specifications
IT WAS REPORTED THAT, DURING INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE ENERGY WAS LOW. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901777 ↗MalfunctionApr 9, 2026Nonstandard Device; Failure to Power Up
IT WAS REPORTED THAT PRIOR TO THE RETROGRADE INTRARENAL URETEROSCOPY SURGERY (RIRS) PROCEDURE, THE CONSOLE WAS NOT SWITCHING ON. 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 24834998 ↗MalfunctionApr 7, 2026Output below Specifications
IT WAS REPORTED THAT DURING THE PREPARATION OF THE PROCEDURE, IT WAS FOUND THAT THE CONSOLE'S ENERGY WAS LOW. THE PROCEDURE WAS COMPLETED USING SAME CONSOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811367 ↗MalfunctionFeb 20, 2026Output below Specifications
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE'S POWER WAS INSUFFICIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401767 ↗MalfunctionFeb 19, 2026Nonstandard Device; Smoking
IT WAS REPORTED THAT THE DEBRIS SHIELD IS BURNT AND SMOKE WAS RISING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385436 ↗
Other Lumenis Ltd. products
All Lumenis Ltd. devices →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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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