VersaPulse PowerSuite 100WRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07290109140551), received between Feb 13, 2019 and Sep 11, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fire

  It was reported that during procedure, there were sparks coming from the console. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736937 ↗
• MalfunctionMar 25, 2026Output below Specifications; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE CONSOLE WOULD DISPLAYED RED SCREEN AND EVEN WHEN THE POWER IS TURNED ON, THE CONSOLE SHUTS OFF IMMEDIATELY. ALSO, THE CONSOLE WOULD NOT TURN ON. 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 OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694782 ↗
• MalfunctionSep 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL PROCEDURE, WHILE THE PATIENT WAS SEDATED, THE POWER KEY PART WAS SPINNING FREELY. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163810 ↗
• MalfunctionMay 21, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE THE CONSOLE HAD A BURNT SMELL. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065279 ↗
• MalfunctionAug 5, 2024Defective Device; Output below Specifications; Noise, Audible; Defective Device; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS A CRACKLING SOUND, AND THE OUTPUT GOT WEAK. IN ADDITION, THERE WAS AN AIMING BEAM ISSUE. 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 19905958 ↗
• MalfunctionApr 16, 2024Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE A FAULT WAS DISPLAYED BY THE CONSOLE AND THE OUTPUT DROP. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121106 ↗
• MalfunctionNov 28, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING PROCEDURE, THE CONSOLE ISSUED ERROR CODE "ALL LASERS MALFUNCTIONING". THE ERROR PERSISTED EVEN AFTER THE CONSOLE WAS REBOOTED. THE PROCEDURE WAS CANCELLED 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 18223661 ↗
• MalfunctionMar 30, 2022No Display/Image; No Display/Image

  A USER FACILITY REPORTED THAT DURING A LASER PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W LASER SYSTEM WAS BEING UTILIZED, THE SCREEN WENT BLACK. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE DEVICE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. THE DELAY WAS APPROXIMATELY 25 MINUTES AND THE PROCEDURE COMPLETED WITHOUT INCIDENT OR COMPLICATION. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13949352 ↗
• MalfunctionFeb 15, 2022Failure to Power Up; Failure to Power Up

  THIS COMPLAINT WAS ORIGINALLY REPORTED TO LUMENIS ON THE 6-JAN-2022 AS NOT HAVING OCCURRED DURING A PROCEDURE (THUS NO PATIENT INVOLVED). ON 28-JAN-2022 LUMENIS RECEIVED A USER FACILITY SUBMITTED (B)(6) REF: (B)(4). THE NEW INFORMATION HAS BEEN ADDED TO THE COMPLAINT. COMPLAINT DESCRIPTION "PATIENT ASLEEP FOR HOLEP. KEY PORT WAS FOUND TO BE FAULTY, WOULD NOT TURN ON. PROCEDURE ABANDONED AND PATIENT WOKEN UP AND REBOOKED" AND "PATIENT UNDERWENT AN ANESTHETIC AND INVASIVE ARTERIAL LINE IN PREPARATION FOR HOLEP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534420 ↗
• MalfunctionFeb 8, 2022Failure to Sense; Failure to Sense

  A FOREIGN USER FACILITY REPORTED THE DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100 WAS BEING UTILIZED, THE SYSTEM WOULD NOT STOP LASING EVEN AFTER THE FOOT SWITCH WAS RELEASED. THE OPERATING DOCTOR SWITCHED TO A TURP PROCEDURE IN ORDER TO COMPLETE THE CASE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477900 ↗
• MalfunctionJan 23, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W LASER WAS BEING UTILIZED, THE DISPLAY PRESENTED ERROR AND THE FOOTSWITCH STOPPED WORKING. IT WAS FOUND THAT A WIRE WAS DISCONNECTED. HOSPITAL'S LOCAL ENGINEER RECONNECT THE WIRING AND THEY WERE ABLE TO CONTINUE WITH THE PROCEDURE USING THE SAME DEVICE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13329880 ↗
• MalfunctionSep 30, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W WAS BEING UTILIZED, THE LASER STOPPED WORKING. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE DEVICE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553625 ↗
• MalfunctionJun 23, 2021Optical Problem; Optical Problem

  A USER FACILITY REPORTED THAT DURING A STONE REMOVAL PROCEDURE, IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100 W LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR MESSAGE CASE SAVER MODE WITH A RED SCREEN. THE PHYSICIAN ELECTED TO CONTINUE THE PROCEDURE WITH AN ALTERNATE DEVICE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048070 ↗
• MalfunctionJun 7, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W WAS BEING UTILIZED, THE SYSTEM HAD BEEN REBOOTED SEVERAL TIMES. UNABLE TO CONTINUE WITH THE SYSTEM AN ALTERNATE DEVICE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945776 ↗
• MalfunctionMay 23, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W WAS BEING UTILIZED, THE LASER SHUT DOWN. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE DEVICE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE ALTERNATE DEVICE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868480 ↗
• MalfunctionApr 21, 2021Unexpected Shutdown; Unexpected Shutdown

  LUMENIS WAS INFORMED BY A FOREIGN DISTRIBUTOR THAT A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W LASER SYSTEM WAS BEING UTILIZED, THE LASER TURNED OFF. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. NO REPORT OF PATIENT COMPLICATIONS, WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699428 ↗
• MalfunctionFeb 24, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A USER FACILITY REPORTED THAT DURING A CYSTO, LASER RT STONE W/ BASKET AND STENT PROCEDURE, IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100 W LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR MESSAGE AND STOPPED WORKING. UNABLE TO CONTINUE WITH THE SYSTEM AN ALTERNATE DEVICE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371134 ↗
• MalfunctionFeb 1, 2021Complete Loss of Power; Complete Loss of Power

  A FOREIGN USER FACILITY REPORTED THAT MAINS CIRCUIT BREAKER TRIPPING OUT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W WAS BEING UTILIZED. WHEN MAINS CAME BACK ONLINE, SYSTEM DID NOT POWERED. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256840 ↗
• InjuryFeb 1, 2021Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W LASER WAS BEING UTILIZED, A NURSE ACTUALLY WALKED BY THE LASER WHILE THE SYSTEM WAS ON AND ACCIDENTALLY KNOCKED OFF THE FIBER PORT AND GOT HER CLOTHES BURNT IN THE HIP AREA, WHICH BURNT THE SKIN AS WELL. ACCORDING TO THE USER, THE LASER WAS WORKING FINE AFTER ATTACHING NEW FIBER. NO REPORT OF PATIENT INJURY OR COMPLICATIONS WAS RECEIVED AS THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER.

  Patient problems: Burn(s)

  MAUDE report 11256837 ↗
• MalfunctionDec 9, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W LASER WAS BEING UTILIZED, THE DISPLAYED TURNED BLACK. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. NO REPORT OF PATIENT COMPLICATIONS, WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10974239 ↗
• MalfunctionNov 1, 2020Failure to Deliver Energy; Optical Problem; Failure to Deliver Energy; Optical Problem

  A FOREIGN USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W LASER SYSTEM WAS BEING UTILIZED, THE LASER LOST POWER AND POPPING SOUND WAS HEARD COMING FROM THE AREA OF THE FIBER. WHEN THEY RELEASED THE FOOT-SWITCH, THEY NOTICED THE LASER CONTINUED TO FIRE EVEN AFTER RELEASING THE FOOT-SWITCH. EMERGENCY SWITCH WAS USED TO STOP THE SYSTEM. NOT HAVING A SPARE BLAST-SHIELD THE FACILITY HAD TO CANCEL THE PROCEDURE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10767668 ↗
• MalfunctionAug 20, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A CYSTO RIGHT RETROGRADE PROCEDURE WITH RIGHT STENT PLACEMENT ON A 26-WK PREGNANT FEMALE, IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100 W LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR MESSAGE AND STOPPED WORKING. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND RESCHEDULED. NO REPORT OF PATIENT COMPLICATIONS, WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10429923 ↗
• MalfunctionAug 3, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100W LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED A MESSAGE "ALL LASER MALFUNCTION" AND THE LASER REMAINED INOPERABLE. UNABLE TO CONTINUE WITH THE DEVICE, THE FACILITY BROUGHT IN AN ALTERNATE LASER TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10355368 ↗
• MalfunctionJun 23, 2020Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 100 W LASER WAS BEING UTILIZED, THERE WAS A POP SOUND AND THE FIBER SMELLED LIKE SMOKE. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE METHOD WAS USED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10182700 ↗
• MalfunctionFeb 27, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS VERSAPULSE 100W WAS BEING UTILIZED, THE SYSTEM SUDDENLY STOPPED WORKING. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE METHOD WAS USED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9761381 ↗