Lumenis Pulse 100HRecalls & reported problems across all models
Lumenis Ltd. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 3 models of Lumenis Pulse 100H by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2019 and Sep 24, 2026 — classified as 3 injuries, 100 malfunctions.
The most frequently reported specific device problem is “Output below Specifications” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Lumenis Pulse 100H problems
Device problems
- Output below Specifications24
- Smoking19
- Defective Device16
- Device Displays Incorrect Message13
- Failure to Deliver Energy12
- Noise, Audible12
- Adverse Event Without Identified Device or Use Problem6
- Communication or Transmission Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Known Impact Or Consequence To Patient9
- Radiation Burn2
- Blood Loss1
- Burn(s)1
Lumenis Pulse 100H models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lumenis Pulse 100HPowered Laser Surgical Instrument76 reports
- Lumenis Pulse 100HPowered Laser Surgical Instrument26 reports
- Lumenis Pulse 100HPowered Laser Surgical Instrument1 report
Recent Lumenis Pulse 100H adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891869 ↗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 ↗MalfunctionAug 18, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306557 ↗MalfunctionApr 22, 2026Output below Specifications
IT WAS REPORTED THAT THE DEVICE HAD A LOW POWER. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957410 ↗MalfunctionApr 22, 2026Nonstandard Device; Smoking; Noise, Audible
IT WAS REPORTED THAT DURING PROCEDURE, A LOUD BANG WAS HEARD, AND A BURNING SMELL WAS NOTICED. THE SYSTEM WAS DOWN. IT WAS INDICATED THAT THE BLAST SHIELD WAS BURNT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956172 ↗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 ↗MalfunctionMar 30, 2026Smoking; Noise, Audible
IT WAS REPORTED THAT AN ABNORMAL NOISE AND A BURNING SMELL WERE NOTICED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716393 ↗MalfunctionMar 25, 2026Output below Specifications
IT WAS REPORTED THAT THE OPTIC WAS FOUND BLOWN RESULTING IN LOW POWER OUTPUT. THE CONSOLE IS NOT USED TO TREAT PATIENTS BUT IS USED FOR TEST ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689561 ↗MalfunctionMar 17, 2026Output below Specifications
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, IT WAS NOTICED BY THE PHYSICIAN THAT THE CONSOLE HAD LACK OF POWER. ALSO, THE DEBRIS SHIELD WAS CHANGED TWICE IN 10 DAYS. NO FURTHER INFORMATION ABOUT THE PATIENT AND PROCEDURE OUTCOME ARE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618247 ↗MalfunctionMar 9, 2026Output below Specifications
IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE SHOWED LOW POWER WHILE LASING, ALTHOUGH NO ERROR APPEARED ON THE SCREEN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552622 ↗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 17, 2026Unexpected Shutdown
IT WAS REPORTED THAT DURING PREPARATION FOR A RETROGRADE INTRARENAL SURGERY (RIRS), THE DEVICE TURNS ON MOMENTARILY, THEN SHUTS ITSELF OFF. 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 24369177 ↗MalfunctionFeb 16, 2026Output 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 24354992 ↗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 ↗
Other Lumenis Ltd. products
All Lumenis Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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