Lumenis Pulse 120H (UDI 07290109140513)Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 07290109140513), received between Jan 9, 2019 and Jul 22, 2026 — classified as 7 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (36 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Nonstandard Device; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906337 ↗
• MalfunctionMar 5, 2026Smoking

  IT WAS REPORTED THAT WHEN THE FIBER WAS CONNECTED TO THE CONSOLE, IT STARTED BURNING, WHICH CAUSED THE FIBER PORT AREA TO SMOKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525064 ↗
• MalfunctionDec 23, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CONSOLE HAD LOW POWER. THE BLAST SHIELD AND FIBER WERE REPLACED; HOWEVER, THERE WAS NO IMPROVEMENT. NO ERROR CODES WERE OBSERVED. 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 23879678 ↗
• MalfunctionNov 18, 2025Defective Device; Output below Specifications; Defective Device; Output below Specifications

  IT WAS REPORTED THAT THE HEALTH CARE FACILITY HAS REPORT PROBLEMS OF LOW POWER AND OTHER ISSUES. THERE WERE NO ADDITIONAL DETAILS REPORT, INCLUDING THE TIME OF THE EVENT AND PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23588375 ↗
• MalfunctionNov 17, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING A PREVENTIVE MAINTENANCE, THE FIELD SERVICE ENGINEER FOUND THE BRICK HAD LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577321 ↗
• MalfunctionNov 12, 2025Nonstandard Device; Smoking; Nonstandard Device; Smoking

  IT WAS REPORTED THAT DURING START UP, A SMOKE OR BURNING SMELL WAS NOTICED COMING OUT FROM THE SIDE OF THE UNIT. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536590 ↗
• MalfunctionMay 16, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR 188 DISPLAYED DURING STARTUP. 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 22038007 ↗
• MalfunctionApr 4, 2025Defective Device; Unexpected Shutdown; Defective Device; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A STONE LASER PROCEDURE, THE CONSOLE SHUT OFF AND NO ERROR CODES WERE REPORTED. THE CONSOLE WAS REBOOTED A COUPLE TIMES, THE SCREEN FROZE UP AND THE CONSOLE DID NOT WORK. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE CASE 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 21774865 ↗
• MalfunctionDec 11, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE, THE CORD OF THE FOOT PEDAL WAS FRAYED. THE PROCEDURE WAS NO COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 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 20907086 ↗
• MalfunctionNov 13, 2024Defective Device; Output below Specifications; Defective Device; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE WAS DISPLAYING LOW POWER. NO ERROR MESSAGES WERE DISPLAYED. WHAT IS OCCURRING IS THAT WHEN THE CONSOLE IS BEING USED, THE DEBRIS SHIELD AND FIBER ARE NOT TRANSMITTING THE HOLMIUM POWER THROUGH BOTH PARTS. THE RESULT IS LOW POWER TRANSMISSION THROUGH THE FIBER. THE DEBRIS SHIELD WAS DAMAGED. THE TECH REPLACED THE DEBRIS SHIELD AND THE FIBER TO RESOLVE THE EVENT. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678805 ↗
• MalfunctionMay 1, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE LASER WOULD NOT POWER ON AT ALL. BREAKERS WERE CHECKED AND A DIFFERENT OUTLET WAS TRIED, AND THE LASER STILL DOES NOT WORK. THEY WERE UNABLE TO START THE PROCEDURE, DUE TO THIS THE PROCEDURE WAS CANCELLED. THE PATIENT WAS PRESENT AND UNDER GENERAL ANESTHESIA. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226817 ↗
• MalfunctionDec 22, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE, ERROR 188 WAS DISPLAYED AND WOULD NOT CLEAR. THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. 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 18383110 ↗
• MalfunctionSep 25, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE ENERGY WAS LOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805666 ↗
• MalfunctionAug 16, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS WORKING IN LOW POWER. THEN, CASE SAVER MODE WAS ACTIVATED AND ERROR 63 WAS PROMPTED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561411 ↗
• MalfunctionMar 3, 2023Device Displays Incorrect Message; Unintended Application Program Shut Down; Device Displays Incorrect Message; Unintended Application Program Shut Down

  IT WAS REPORTED THAT LASER SHUT DOWN IN THE MIDDLE OF CASE. LASER RAN FINE AN HOUR AHEAD. THEN, ERROR 11 (MAIN CONTROLLER COMMUNICATION (RECOVERY FAILED)) WAS DISPLAYED. MACHINE WAS MANUALLY SHUT OFF AND WHEN MACHINE WAS TURNED ON AGAIN IT HAD THE SAME ISSUES. IT WAS NOTED THAT THE CONSOLE DISPLAYED ERRORS 11, 101, AND 120 AT SEPARATE TIMES, AND ALL 3 OF WHICH POINT TO MMCU COMM PROBLEMS. 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 WHOSE WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479498 ↗
• InjurySep 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PUDDLE OF ABOUT THE SIZE OF A CUP WAS NOTED UNDER THE CONSOLE AFTER THE PROCEDURE. THERE WAS NO DRIPPING OR LEAK OBSERVED. THE PHYSICIAN THEN TOUCHED THE BIS SENSOR OF THE BRAIN MONITORING SYSTEM (A STICKER-LIKE ELECTRODE ON THE FOREHEAD), CAUSING A 1MM BLISTER ON HIS LEFT RING FINGER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 15349840 ↗
• MalfunctionJul 14, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  A USER FACILITY REPORTED THAT AT THE BEGINNING OF A PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR 58, TEST FAILED 152, LASER DECK - SHUTTER TEST FAIL 153, LASER DECK - SHUTTER NOT CLOSED. 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 15011061 ↗
• MalfunctionJul 11, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER WAS BEING UTILIZED, THE DISPLAY PRESENTED ERROR "LASER OVERHEATED". THE USER ATTEMPTED TO RESTART THE LASER SEVERAL TIMES TO NO AVAIL. UNABLE TO COMPLETE THE PROCEDURE, A STENT WAS USED AND 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 14976920 ↗
• MalfunctionJun 21, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THIS COMPLAINT WAS ORIGINALLY REPORTED TO LUMENIS ON THE (B)(6) 2022 AS NOT HAVING OCCURRED DURING A PROCEDURE (THUS NO PATIENT INVOLVED). ON 14-JUN-2022 LUMENIS RECEIVED A USER FACILITY SUBMITTED MHRA REF: 2022/005/011/501/012. THE NEW INFORMATION HAS BEEN ADDED TO THE COMPLAINT. COMPLAINT DESCRIPTION "SURGEON ATTEMPTED TO LASER STONE INTRA-OPERATIVELY AND LASER MACHINE HAS FAILED STATING NUMEROUS ERRORS. ERROR CODES ARE 240, 268, 162, 224. THIS HAS RESULTED IN HAVING TO ABANDON PROCEDURE AND PATIENT WILL NEED TO RETURN TO THEATRE AT LATER DATE. PATIENT DID NOT COME TO ANY HARM. URETERIC STENT INSERTED TO PROTECT THEIR URETER AND KIDNEY UNTIL NEW DATE FOR THE PROCEDURE CAN BE REBOOKED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754091 ↗
• InjuryMay 25, 2022Use of Device Problem; Use of Device Problem

  A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER WAS BEING UTILIZED WITH A MOSES 550 FIBER. THE PHYSICIAN ACCIDENTALLY PRESSED THE FOOTSWITCH AND FIRED AT THE DRAPE THAT WAS USED FOR THE OPERATION, A FIRE BROKE OUT, THE PATIENT AND THE PHYSICIAN GOT BURNT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: Burn(s)

  MAUDE report 14494630 ↗
• InjuryMay 3, 2022Overheating of Device; Overheating of Device

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER WAS BEING UTILIZED WITH A NON-LUMENIS FIBER, THE FIBER MELTED MID-CASE AT THE CONNECTION POINT. WHEN THE NURSE WENT TO REMOVE THE FIBER SHE FELT A BURNING SENSATION ON HER RIGHT INDEX FINGER AND THUMB. THE SURGEON TURNED THE MACHINE OFF AND THE NURSE LEFT THE ROOM TO PUT ICE ON HER FINGER AND GO TO OCCUPATIONAL HEALTH WHERE SHE WAS GIVEN SILVADENE OINTMENT AND FINGER WAS WRAPPED IN GAUZE AND TAPE. NO REPORT OF PATIENT INJURY OR COMPLICATIONS WAS RECEIVED AS THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER.

  Patient problems: Burn(s)

  MAUDE report 14268414 ↗
• MalfunctionMar 24, 2022Smoking; Smoking

  A FOREIGN USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER WAS BEING UTILIZED, THE UNIT STARTED SMOKING. THE FACILITY SHUT OFF THE UNIT AND DID NOT USE IT. AFTER TEN MINUTES DELAY TO CLEAR THE OPERATING ROOM OF SMOKE, A SECOND LASER 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 13886210 ↗
• MalfunctionFeb 15, 2022Connection Problem; Connection Problem

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS PULSE 120 LASER WAS BEING UTILIZED WITH A MOSES 200 FIBER, THE SYSTEM WAS NOT RECOGNIZING THE FIBER. THE FACILITY REPLACED THE FIBER TO A SECOND AND THIRD MOSES 200 FIBER, AND THEY TOO WERE UNRECOGNIZED. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS CANCELED. 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 13531466 ↗
• MalfunctionDec 28, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120H WAS BEING UTILIZED, ERROR CODE 216 APPEARED ON THE SCREEN "PLEASE SHUT DOWN THE SYSTEM AND RESTART AFTER 1 MINUTE". UNABLE TO CONTINUE WITH THE LASER, 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 13091506 ↗
• MalfunctionDec 23, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER WAS BEING UTILIZED, THE DISPLAY PRESENTED ERRORS 208, AND 266, AND THE LASER COULD NO LONGER BE USED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED BY USE OF AN ALTERNATE LASER. 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 13076013 ↗