Lumenis Pulse 100H (REF GA-1008944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07290109145969), received between Oct 6, 2022 and Sep 4, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Unexpected Shutdown

  It was reported that the console shuts off as soon as the fiber was connected and requested a service. Addition information received clarified that the issue occurred during procedure and the procedure had to be postponed due to it being only their laser. The patient was sedated with general anesthesia per their standard protocol at the time of the event. The patient outcome information was unavailable per the customer.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 50601113 ↗
• MalfunctionApr 9, 2026Smoking

  IT WAS REPORTED THAT THE DEVICE MADE A BURNING SMELL. THE DEVICE IS DOWN. THERE WAS NO REPORT OF PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837714 ↗
• MalfunctionFeb 26, 2026Material Integrity Problem; Output below Specifications

  IT WAS REPORTED THAT THE UNIT HAD POWER ISSUES AND THAT THE DEVICE IS NOT LASING TO ITS HIGHEST POTENTIAL. IT WAS NOTED THAT THE PROBLEM INDICATED A PHYSICALLY BROKEN/WORN/DAMAGED OPTICS. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456785 ↗
• MalfunctionFeb 2, 2026Smoking

  IT WAS REPORTED THAT THIS UNIT WILL NOT TURN ON AND BURN SMELL COMING FROM UNIT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240838 ↗
• MalfunctionJan 23, 2026Communication or Transmission Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A NEPHROLITHOTOMY PROCEDURE TO TREATED KIDNEY STONES, THE FIBER BURNED, AND THE LASER EMITTED A LOUD SOUND AS IF IT HAD OVERHEATED OR BURNED. THE FIBER WAS DAMAGED BY THE LASER, WHICH SUBSEQUENTLY BEGAN REPORTING A FAULT. AS A RESULT, THE PROCEDURE WAS DISCONTINUED. THE PATIENT WAS UNDER GENERAL ANESTHESIA; THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160547 ↗
• MalfunctionJan 16, 2026Failure to Fire; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A NEPHROLITHOTOMY PROCEDURE, THE CONSOLE DID NOT FIRE AND DISPLAYED A MISFIRE ERROR. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS UNDER GENERAL ANESTHESIA, BUT THERE WERE NO PATIENT COMPLICATIONS 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 24096673 ↗
• MalfunctionJun 25, 2025Nonstandard Device; Smoking; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Smoking; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE UNIT FAILED TO POWER ON AFTER BEING MOVED TO ANOTHER ROOM. RETURNING IT TO THE ORIGINAL LOCATION DID NOT RESOLVE THE ISSUE. WHILE INSPECTING IT, THE UNIT SPARKED SEVERAL TIMES SO IT WAS UNPLUGGED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333113 ↗
• MalfunctionMay 22, 2025Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE THE CONSOLE WAS EMITTING A LOUD NOISE AND THERE WAS A BURNING SMELL. THE PROCEDURE WAS COMPLETED. 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 22071861 ↗
• MalfunctionMay 14, 2025Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE EMITTED A NOISE ON START UP AS WELL AS A BURNING SMELL DURING USE. CASES WERE COMPLETED AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023423 ↗
• MalfunctionApr 30, 2025Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTPUT POWER WAS LOSS AND ERROR CODE WAS DISPLAYED. THE PROCEDURE WAS COMPLETE WITH THIS DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940019 ↗
• MalfunctionMar 20, 2025Device Displays Incorrect Message; Communication or Transmission Problem; Output below Specifications; Device Displays Incorrect Message; Communication or Transmission Problem; Output below Specifications

  IT WAS REPORTED THAT THERE WAS AN ERROR CODE 303, HIGH ENERGY, PRESENT AND ONLY WORKS UP TO 12W. THE DEBRIS SHIELD WAS REPLACED, AND ERROR STILL PERSISTS. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AT LOW POWER WITH NO PATIENT COMPLICATIONS THIS EVENT IS BEING REPORTED FOR LOW POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657681 ↗
• MalfunctionMar 13, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THERE ARE CONCERNS FOR LOW POWER ON THE CONSOLE AND THE CUSTOMER IS REQUESTING A QUOTE FOR REPLACING THE BRICK. NO FURTHER INFORMATION PROVIDED ON PROCEDURE OR PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597181 ↗
• MalfunctionFeb 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, THE EMERGENCY STOP BUTTON BROKE AND FELL OFF. THERE WAS NO PATIENT AND PROCEDURE OUTCOME PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21336608 ↗
• MalfunctionFeb 3, 2025Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE UNIT HAD A SMOKING SMELL AND WAS NOT LASING AT THE PREVIOUS POWER. THE FUSE WAS CHANGED ON THE CONSOLE, HOWEVER, THE PROBLEM PERSISTED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299455 ↗
• MalfunctionSep 16, 2024Display or Visual Feedback Problem; Nonstandard Device; Defective Device; Display or Visual Feedback Problem; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT PRIOR TO HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE THE EQUIPMENT DISPLAY WAS FROZEN AFTER BEING TURNED ON AND THE SYSTEM DID NOT WORK. WHEN TURNED THE KEY ON CANNOT HOLD THE AC CONTROL THE SYSTEM. THE PROCEDURE WAS CANCELLED, THERE WAS NO PATIENT COMPLICATION. 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 20231328 ↗
• MalfunctionJul 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE KEY SWITCH WAS BROKEN. THE BLACK CONNECTION PORT HAS BEEN BROKEN FROM INSIDE THE CONSOLE. THE PROCEDURE WAS CANCELLED. 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 19802191 ↗
• MalfunctionJun 5, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING PROCEDURE THE LASER CONSOLE SHUT OFF AFTER PLUGGING IN THE FIBER INTO PORT. THE PROCEDURE WAS NOT COMPLETED, THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. EVENT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468883 ↗
• MalfunctionMay 15, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE PRESENTED LOW POWER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326004 ↗
• MalfunctionApr 4, 2024Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT ERROR 304: "ENERGY TOO LOW" DISPLAYED DURING LASING. 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 19047387 ↗
• MalfunctionAug 25, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOT PEDAL IS NOT WORKING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624405 ↗
• MalfunctionAug 15, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ERROR 303 (ENERGY TO HIGH) WAS RECEIVED. THE PROCEDURE WAS NOT COMPLETED AS A RESULT OF THE EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552289 ↗
• MalfunctionJun 2, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WERE ISSUES WITH THE FOOT PEDAL. ERRORS 405 (FOOTSWITCH NUMBER 1 SHORTED.), 425 (NUMBER 2 FOOTSWITCH SHORTED.), AND 429 (FOOTSWITCH3 BROKEN) WERE RECEIVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050231 ↗
• MalfunctionMar 14, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT IN PREPARATION FOR THE PROCEDURE, THE PATIENT HAD BEEN SEDATED WITH ANESTHESIA. UPON ENTERING THE OPERATING ROOM (OR) FOR THE PROCEDURE, AFTER THE CONSOLE WAS TURNED ON THEY IMMEDIATELY SAW THAT THE CASE SAVER ERROR WAS RECEIVED. THE PHYSICIAN DETERMINED THAT HE WOULD NOT BE ABLE TO USE THE CONSOLE FOR THE PROCEDURE, SO THE PROCEDURE WAS CANCELLED. A FIBER HAD NEVER BEEN CONNECTED TO THE CONSOLE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541351 ↗
• MalfunctionFeb 15, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT THE CONSOLE SHUT OFF DURING THE PROCEDURE. THE CONSOLE WAS RESTARTED BUT IT SHUT OFF AGAIN. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378498 ↗
• MalfunctionDec 22, 2022Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR 425 (#2 FOOTSWITCH SHORTED) OCCURRED. THE FOOTSWITCH NEEDS REPLACEMENT. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT OUTCOME REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036281 ↗