Lumenis Pulse 120H (REF GA-0006801)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07290109145426), received between Aug 29, 2022 and Sep 16, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Integrity Problem

  It was reported that during procedure, the device malfunctioned. The procedure was not completed due to this event. There were no patient complications reported. This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788914 ↗
• MalfunctionMay 16, 2026Communication or Transmission Problem; Firing Problem

  IT WAS REPORTED THAT ERROR 150: "LASER DECK - FIBER NOT CONNECTED" DISPLAYED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. 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 25196077 ↗
• MalfunctionApr 30, 2026Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LASER COMES OUT EVEN WITHOUT PRESSING THE FOOTSWITCH. 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 25053125 ↗
• MalfunctionMar 10, 2026Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD LOW POWER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24564985 ↗
• MalfunctionFeb 17, 2026Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS EXPERIENCING LOW POWER ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372978 ↗
• MalfunctionFeb 5, 2026Nonstandard Device

  IT WAS REPORTED THAT THE CONSOLE CANNOT EMIT LASER. FIELD SERVICES OF THE CONSOLE IDENTIFIED THAT THERE WAS A BURNING SMELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274878 ↗
• MalfunctionNov 30, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677070 ↗
• MalfunctionNov 19, 2025Fire; Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER CAUSED A SPARK THAT CAUGHT THE DRAPES OVER THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600877 ↗
• MalfunctionAug 27, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT, CONSOLE HAS SYMPTOMS OF LOW ENERGY OUTPUT. THE ISSUE WAS IDENTIFIED WITH A POWER METER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905572 ↗
• MalfunctionJul 31, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAS LOW POWER OUTPUT. THERE WERE NO ERRORS AND NO ISSUES WITH ANY FIBERS OR BLAST SHIELDS. THE PROCEDURE WAS COMPLETED WITH THIS ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677371 ↗
• MalfunctionJul 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING PREPARATION FOR THE PROCEDURE, THE CAPACITOR BANK EXPLODED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543547 ↗
• MalfunctionJun 26, 2025Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE CONSOLE DISPLAYED MULTIPLE ERROR CODES: 273: CHECK FOR ADDITIONAL FAULT, ERROR CODE 253: LASING, SAFETY PYRO LOW LIMIT FAIL, ERROR CODE 62: AIMMING BEAM OFF AND ERROR CODE 65 - BRICK 3 NOT WORKING CASE SAVER MODE. THIS PROCEDURE WAS NOT COMPLETED. 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 22342790 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED IN ORDER TO PRESENT THE AUTHORS EXPERIENCES WITH THE UPGRADED MOSES 2.0 TECHNOLOGY IN PATIENTS UNDERGOING HOLEP FOR BPH, COMPARING IT TO THE USE OF MOSES 1.0 TECHNOLOGY AT OUR INSTITUTION. THE STUDY OCCURRED WITH 196 PATIENTS UNDER ONE SURGEON FROM DECEMBER 2020 TO SEPTEMBER 2023 WITH A PULSE 120 MOSES HOLMIUM LASER. OUT OF THE 196 PATIENTS, 146 WERE PATIENTS WHO UNDERWENT THE PROCEDURE USING THE MOSES 1.0 TECHNOLOGY AND 50 PATIENTS UNDERWENT THE PROCEDURE USING MOSES 2.0 TECHNOLOGY. POSTOPERATIVE COMPLICATIONS INCLUDED PERSISTENT HEMATURIA, CLOT RETENTION, URETHRAL STRICTURES, BLADDER NECK CONTRACTION AND STRESS URINARY INCONTINENCE. ONE PATIENT FROM THE MOSES 1.0 GROUP EXPERIENCED PROLONGED GROSS HEMATURIA, REQUIRING 48-HOUR CATHETERIZATION AND HOSPITAL STAY. ADDITIONALLY, FOUR PATIENTS RETURNED TO THE EMERGENCY ROOM (ER) WITH GROSS HEMATURIA, ONE OF WHOM ALSO RECEIVED A POSTOPERATIVE BLOOD TRANSFUSION. ONE PATIENT FROM THE MOSES 2.0 GROUP RETURNED TO THE ER WITH GROSS HEMATURIA, REQUIRING READMISSION. AT THE 6 MONTHS FOLLOW-UP, ONE PATIENT IN THE M

  Patient problems: Hematuria; Stenosis; Urethral Stenosis/Stricture; Urinary Incontinence; Urinary Retention

  MAUDE report 22099435 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SYSTEM EXPERIENCED MISALIGNMENT ISSUES, WHICH RESULTED IN THE SURGEON'S FINGER BEING BURNED. THERE WAS NO PATIENT AND PROCEDURE OUTCOME.

  Patient problems: Burn(s)

  MAUDE report 22037742 ↗
• MalfunctionApr 8, 2025Device Displays Incorrect Message; Communication or Transmission Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A URETEROSCOPY WITH A LASER LITHOTRIPSY PROCEDURE, MULTIPLE FIBERS WERE ATTEMPTED TO BE USED, HOWEVER, THE CONSOLE REPEATEDLY DISPLAYED THE ERROR CODE 48: "FIBER OTHER THAN LUMENIS SIS DETECTED. PLEASE REPLACE FIBER." ON ALL FOUR FIBERS. THE PROCEDURE WAS NOT COMPLETED AND HAD TO BE CANCELLED. 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 21800513 ↗
• MalfunctionNov 27, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT, THE CONSOLE SHUT DOWN DURING A PROCEDURE AND WAS UNABLE TO BE TURNED BACK ON. THERE IS NO PATIENT AND PROCEDURE OUTCOME REPORTED. 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 20790604 ↗
• MalfunctionNov 12, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE PHYSICIAN WAS HAVING A HARD TIME CUTTING THE TISSUE, SUGGESTING THE CONSOLE WAS DELIVERING LESS POWER. NO ERROR CODES WERE DISPLAYED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669520 ↗
• MalfunctionNov 11, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LASER SPARKED WHEN IT WAS PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654015 ↗
• MalfunctionOct 22, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE LASER WAS VERY "ANEMIC" (LOW POWER) THE BIOMED CONTACTED A SERVICE CALL, AS WE DO TRY TO TROUBLE SHOOT THE LASERS OURSELVES IF WE CAN THROUGH RE-START, UPLOADING THE ERROR LOGS TO BOSTON SCI, AND CHANGING THE BLAST SHIELDS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502022 ↗
• MalfunctionSep 2, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE PROMPTED ERRORS 273, 254, AND 162, AND THE PROCEDURE COULD NOT BE COMPLETED. IT WAS UNKNOWN IF THE PATIENT WAS UNDER SEDATION. THERE WERE NO PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD-FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117749 ↗
• MalfunctionJun 12, 2024Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Output below Specifications; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE IS WORKING AT REDUCED POWER. NO ERRORS WERE REPORTED. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521772 ↗
• MalfunctionJun 5, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOT PEDAL IS DAMAGED. 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 19472163 ↗
• MalfunctionMay 22, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS IDENTIFIED THAT THE CONSOLE WAS WORKING AT REDUCED POWER. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372900 ↗
• MalfunctionMay 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE TIME OF THE PROCEDURE, THE PROCEDURE ROOM HAD TO BE CHANGED. WHEN PREPARATION WAS COMPLETE AND AT THE START OF INDUCTION, A WATER LEAK FROM THE LASER CONSOLE WAS OBSERVED. ONCE THE PATIENT HAD BEEN SEDATED, THE BIOMEDICAL ENGINEER ADVISED NOT USING THE LASER TO AVOID THE RISK OF OVERHEATING. THE PROCEDURE WAS CANCELLED DESPITE THE PATIENT UNDERGOING A NEPHROSTOMY. 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 19255980 ↗
• MalfunctionDec 19, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LASER CONSOLE BLEW TWO BLAST SHIELDS. THE FIBER IS NOW STUCK ON THE LASER AFTER THE SECOND BLAST SHIELD WAS BLOWN. THE PATIENT HAD BEEN SEDATED WITH GENERAL ANESTHESIA, HOWEVER, ONCE THE ISSUE STARTED AND THE LASER WAS NO LONGER FUNCTIONING THE PROCEDURE WAS ABORTED. THIS DID NOT RESULT IN ANY BLEEDING ISSUES, BUT THE STONES WOULD NOT BE BUSTED UP WITHIN THE BLADDER. THE CONSOLE WAS CHECKED THE NEXT DAY AND NO ISSUE WAS FOUND. THE PATIENT WILL BE BROUGHT BACK IN ANOTHER DAY TO FINISH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356662 ↗