VersaPulse PowerSuite VersaPulse PowerSuite 100W (REF 0638-803-00)Recalls & reported problems
Lumenis Ltd. · Class 2
All models of VersaPulse PowerSuite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This VersaPulse PowerSuite console is a powered laser surgical console. The 69 reports mostly describe power dropping or output falling below spec, the console failing to recognize fibers, and error messages on the display; most involve no patient at all, often found during routine service checks. One report describes a patient with breathing difficulty. No deaths, one injury, and 68 malfunctions. There are no recalls naming this device, and the report count is steady at 26 versus 24 in the prior12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07290109146171), received between Jul 27, 2023 and Sep 30, 2026 — classified as 1 injury, 63 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (45 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.
Reports received per month
Most reported problems
Device problems
- Output below Specifications45
- Adverse Event Without Identified Device or Use Problem7
- Device Displays Incorrect Message6
- Nonstandard Device6
- Smoking6
- Defective Device5
- Appropriate Device Problem Term/Code Not Available4
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Respiratory Insufficiency1
Recent adverse event reports
The 25 most recent of 64 reports, 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 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 ↗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 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 18, 2026Nonstandard Device; Output below Specifications
IT WAS REPORTED THAT THE CONSOLE'S BLAST SHIELD WAS DAMAGED, AND THE CONSOLE'S POWER WAS INSUFFICIENT. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME ISSUES PRESENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377811 ↗MalfunctionFeb 16, 2026Output below Specifications
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE EXPERIENCED A POWER REDUCTION. THE CASE WAS COMPLETED USING THE ORIGINAL DEVICE. 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 24344795 ↗MalfunctionFeb 9, 2026Output below Specifications
IT WAS REPORTED THAT THIS DEVICE HAD ENERGY LOW. THERE WERE NO REPORT OF PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293318 ↗MalfunctionFeb 4, 2026Output below Specifications
IT WAS REPORTED THAT ENERGY WAS LOW DURING INSPECTION, AND THEN THE CONSOLE COULD NOT BE TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259088 ↗MalfunctionJan 29, 2026Output below Specifications
IT WAS REPORTED THAT, BEFORE THE PROCEDURE, THE ENERGY WAS WEAK. THE PATIENT WAS PRESENT AT THE TIME OF THE EVENT. INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215471 ↗MalfunctionJan 22, 2026Power Problem
IT WAS REPORTED THAT THE POWER OF THIS DEVICE WAS INSUFFICIENT. ALSO, DISPLAYED AN ERROR 'ENERGY LOW - PULSE ENERGY IS OVER 50% LOWER THAN REQUESTED.' THERE WERE NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151032 ↗MalfunctionDec 23, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications
IT WAS REPORTED THAT THE CONSOLE PRESENTED LOW WATTAGE. THERE WAS NO PATIENT INVOLVED, AS THE CONSOLE IS A TESTING DEVICE AND NOT USED WITH PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881945 ↗MalfunctionDec 9, 2025Smoking; Smoking
IT WAS REPORTED THAT THE CONSOLE HAD AN UNUSUAL ODOR COMING FROM THE POWER SOCKET. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760500 ↗MalfunctionNov 26, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT A POWER REDUCTION WAS FOUND DURING DAILY INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659943 ↗MalfunctionNov 21, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT THE ENERGY WAS LOW. THE PROCEDURE WAS FINALLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617173 ↗MalfunctionNov 20, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE WAS HAVING LOW POWER. 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 23604765 ↗MalfunctionNov 3, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications
IT WAS REPORTED THAT WHEN CHECKING THE DEVICE, IT WAS FOUND THAT THE POWER WAS LOW. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23457838 ↗MalfunctionOct 30, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER HAD LOW POWER. 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 23425674 ↗MalfunctionOct 28, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT DURING THE PROCEDURE, POWER REDUCTION WAS FOUND. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404785 ↗MalfunctionOct 24, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT THE CONSOLE HAD LOW POWER OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382447 ↗MalfunctionOct 17, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE PHYSICIAN FOUND THE CONSOLE ENERGY WAS WEAK. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327695 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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