Lumenis Pulse 30H (UDI 07290109140698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290109140698), received between Mar 10, 2019 and Jan 14, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Nonstandard Device; Noise, Audible

  IT WAS REPORTED THAT AFTER THE LASER IRRADIATION START, AROUND 20 MINUTES AN UNUSUAL SOUND OCCURS EACH TIME. BURNS WERE CONFIRMED ON THE BLAST SHIELD LENS. IT APPEARED THAT THE CONDENSER LENS BETWEEN THE FIBER PORT AND THE LASER ITSELF HAVE BURNT OUT. THE PROCEDURE WAS DISCONTINUED. THE FIBER, BLAST SHIELD AND THE CONDENSER LENS WERE REPLACED. ON THE NEXT DAY THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT BEING SEDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071393 ↗
• MalfunctionMar 30, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A KIDNEY STONE PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR 02 - SHUTTER ERROR. 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 13949506 ↗
• MalfunctionFeb 17, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A CYSTOSCOPY, LASER STONE W/ BASKET AND STENT PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM STOPPED AND DISPLAYED ERROR 49 "PYRO MAIN DOES NOT EQUAL PYRO SAFE". THE USER FACILITY TRIED TO TROUBLESHOOT BUT AFTER TEN (10) MINUTES DELAY THE PROCEDURE WAS COMPLETED USING A BASKET EXTRACTION. 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 13549393 ↗
• MalfunctionJan 13, 2022Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM STOPPED AND DISPLAYED ERROR 12 "COOLING FLOW SWITCH". 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 13248390 ↗
• MalfunctionSep 26, 2021Failure to Deliver Energy; Failure to Deliver Energy

  LUMENIS WAS INFORMED BY A FOREIGN DISTRIBUTOR THAT A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED WITH A FIBER, "THE 1ST FIBER WAS USED FOR 25 MIN (REUSABLE FIBER, 2/10 USES). THEN DEBRIS SHIELD BURNED AND THE FIBER BROKE. FIBER AND DEBRIS SHIELD CHANGED. 2ND FIBER WAS USED FOR 15 MIN THEN DEBRIS SHIELD BURNT AND FIBER BROKE". ACCORDING TO THE REPORTER THE PROCEDURE WAS STOPPED BECAUSE "NO MORE CONSUMABLES WERE AVAILABLE TO CARRY ON WITH THE TREATMENT". 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 12530944 ↗
• MalfunctionNov 29, 2020Optical Problem; Optical Problem

  ON 25-NOV-2020, A LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT 2300720000-2020-8010 IN WHICH THE DESCRIPTION OF THE EVENT READS, "WHEN THEY ARE USING IT (LUMENIS PULSE 30H) THE (NON-LUMENIS) LASER FIBER ON THE OUTSIDE OF THE PATIENT IS LIGHTING UP, TRIED 3 DIFFERENT LASER FIBERS AND THE ALL DID THAT." "THE VENDOR (LUMENIS) CAME OUT AND VERIFIED MACHINE OPERATION AND BELIEVES THE PROBLEM IS THE (NON-LUMENIS) FIBER THAT WAS USED." 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 10916201 ↗
• MalfunctionNov 12, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM STOPPED AND DISPLAYED ERROR 49, "PYRO MAIN DOES NOT EQUAL PYRO SAFE." 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 10827330 ↗
• MalfunctionApr 5, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, THE SYSTEM STOPPED AND DISPLAYED ERROR 66 "USE AUTHORIZED FIBER". 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 Known Impact Or Consequence To Patient

  MAUDE report 9926524 ↗
• MalfunctionNov 11, 2019Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A BLADDER STONE PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS BEING UTILIZED, "THE FAN STARTED GOING VERY FAST AND A STRONG SMELL/ODOR CAME OUT OF THE SYSTEM. SUDDENLY THE SYSTEM STOPPED AND DISPLAYED ERROR 26".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 Known Impact Or Consequence To Patient

  MAUDE report 9303161 ↗
• MalfunctionJul 23, 2019Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS SLIMLINE 200 DFL FIBER WAS BEING UTILIZED WITH A LUMENIS PULSE 30H LASER, THE FIBER PERFORMANCE ABRUPTLY DECREASED AND THE FIBER NEEDED TO BE EXCHANGED. AFTER EXCHANGING THE FIBER FOR A NEW SLIMLINE 200 DFL, THE FIBER PERFORMANCE ABRUPTLY DECREASED AGAIN, SUBSEQUENTLY BURNING THE BLASTSHIELD. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LASER. NO REPORT OF PATIENT INJURY WAS RECEIVED NOR A REPORT THAT THE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S STATUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815112 ↗
• MalfunctionJul 23, 2019Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS SLIMLINE 200 DFL FIBER WAS BEING UTILIZED WITH A LUMENIS PULSE 30H LASER, THE FIBER PERFORMANCE ABRUPTLY DECREASED AND THE FIBER NEEDED TO BE EXCHANGED. AFTER EXCHANGING THE FIBER FOR A NEW SLIMLINE 200 DFL, THE FIBER PERFORMANCE ABRUPTLY DECREASED AGAIN, SUBSEQUENTLY BURNING THE BLASTSHIELD. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LASER. NO REPORT OF PATIENT INJURY WAS RECEIVED NOR A REPORT THAT THE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S STATUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815003 ↗
• MalfunctionMar 10, 2019Break; Complete Loss of Power; Break; Complete Loss of Power

  A USER FACILITY REPORTED THAT AT THE START OF A PROCEDURE IN WHICH A LUMENIS PULSE 30H WAS TO BE USED, "THE NURSE TURNED THE KEY TO ACTIVATE THE LASER AND THE LASER STARTED TO GO THROUGH ITS WARM UP BUT THEN SHUT OFF BY ITSELF. THE NURSE TURNED THE KEY AND TRIED TO RESTART IT BUT THERE WAS NO RESPONSE FROM THE LASER." THE NURSE TRIED UNPLUGGING THE LASER AND RESTARTING AGAIN, BUT THAT DIDN'T WORK EITHER. AN ALTERNATE LASER WAS BROUGHT IN TO COMPLETE THE CASE. NO REPORT OF PATIENT INJURY WAS RECEIVED, AND THE EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406452 ↗