Moses™ Moses™ 550 D\F\LRecalls & reported problems
Lumenis Ltd. · Class 2
All models of Moses (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Lumenis Moses laser instrument is a powered laser surgical instrument. Of its 163 adverse event reports, 147 are malfunctions and 15 are injuries, with 1 death. Most describe parts breaking, often the laser fiber, and some describe overheating or smoking at the connection. Burns are mentioned in 12 reports. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 153
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 07290109143453), received between Jun 28, 2019 and Sep 30, 2026 — classified as 1 death, 15 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Break” (104 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break104
- Adverse Event Without Identified Device or Use Problem23
- Nonstandard Device16
- Overheating of Device11
- Defective Device9
- Material Integrity Problem8
- Power Problem6
- Separation Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions135
- Burn(s)12
- Insufficient Information2
- Hematuria1
- Incontinence1
- No Known Impact Or Consequence To Patient1
- Superficial (First Degree) Burn1
- Urinary Incontinence1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952624 ↗MalfunctionSep 23, 2026Nonstandard Device; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873894 ↗MalfunctionSep 11, 2026Break; Material Integrity Problem
It was reported that during procedure, the fiber snapped and sparked. The procedure was completed using another fiber. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735992 ↗MalfunctionAug 31, 2026Break
It was reported that the front end of the fiber was fractured. The procedure was completed with another device. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515449 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204406 ↗MalfunctionAug 4, 2026Break; Smoking
It was reported that during a Holmium laser enucleation of the prostate procedure, fiber started smoking where the fiber connects to the laser. The procedure was completed using another fiber of the same lot number. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132672 ↗MalfunctionJul 22, 2026Break; Gas Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25908539 ↗MalfunctionJul 7, 2026Break; Overheating of Device
IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER CONNECTOR OVERHEATED AND SMOKE WAS SEEN COMING FROM THE CONNECTOR. THE FIBER BROKE AT THE PROXIMAL PART WHEN IT WAS BEING CHANGED. THE PROCEDURE WAS COMPLETED WITH A FIBER REPLACEMENT. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733134 ↗MalfunctionJun 19, 2026Nonstandard Device; Material Integrity Problem
IT WAS REPORTED THAT MOSES FIBER BLAST DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BODY BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563877 ↗MalfunctionJun 10, 2026Break; Gas Output Problem
IT WAS REPORTED THAT AFTER STARTING THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER WAS NOT GIVING THE EXPECTED ENERGY, AND AFTER A COUPLE SHOTS THE DEBRIS SHIELD BURNT OUT AND THE FIBER BROKE. THIS OCCURRED TWICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT REFERS TO THE SECOND FIBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464025 ↗MalfunctionJun 10, 2026Break; Gas Output Problem
IT WAS REPORTED THAT AFTER STARTING THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER WAS NOT GIVING THE EXPECTED ENERGY, AND AFTER A COUPLE SHOTS THE DEBRIS SHIELD BURNT OUT AND THE FIBER BROKE. THIS OCCURRED TWICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT REFERS TO THE FIRST FIBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463988 ↗MalfunctionJun 1, 2026Failure to Fire
IT WAS REPORTED THAT DURING PROCEDURE OUTSIDE THE PATIENT, THE FIBER'S LASER BEAM SHOWED IRRADIATION FAILURE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A CONNECTOR FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349966 ↗MalfunctionMay 14, 2026Break; Nonstandard Device; Smoking
IT WAS REPORTED THAT NO ENERGY CAME OUT FROM THE FIBER WHEN CONNECTED, AND THEN A SMELL OF BURNING WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177200 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT, THE TIP OF THE FIBER BROKE OFF DURING LASERING. THE FIBER WAS REPLACED AND ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117973 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT THIS FIBER BROKE OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24868304 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT, IMMEDIATELY AFTER CONNECTION OF THE FIBER, THE FIBER BROKE AND THE DEBRIS SHIELD BURNT OUT. THE FIBER AND THE DEBRIS SHIELD WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT REFERS TO THE FIBER BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824520 ↗MalfunctionMar 30, 2026Break; Material Integrity Problem
IT WAS REPORTED THAT, DURING PROCEDURE, THERE WAS A LOUD POPPING NOISE AND THE FIBER CRACKED, BLOWING THE DEBRIS SHIELD. THE DEBRIS SHIELD AND THE FIBER WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727690 ↗MalfunctionMar 26, 2026Overheating of Device; Separation Problem
IT WAS REPORTED THAT DURING HOMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE TO TREAT STONES, A BURNING SMELL AND SMOKE WERE NOTICED TO BE COMING FROM THE PLASTIC PROBE OF THE FIBER CONNECTOR WHILE THE FIBER WAS OUTSIDE THE PATIENT. WHEN ATTEMPTING TO REPLACE THE FIBER, THE PROBE BROKE, AND IT WAS NOTICED THAT THE PLASTIC CONNECTION HAD MELTED. THE PROCEDURE WAS COMPLETED WITH A FIBER REPLACEMENT. THERE WERE NO HARMS TO THE PATIENT AND OPERATOR, AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706568 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT DURING A CYSTOLITHOLAPAXY AND PROSTATE ENUCLEATION PROCEDURE, WHILE TAKING IT OUT OF PATIENT THROUGH THE SCOPE IT HAD SPARKS WHEN IT WAS IN SURGEON'S HAND. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581355 ↗MalfunctionMar 6, 2026Break; Nonstandard Device; Peeled/Delaminated
IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE TO TREAT AN ENLARGED PROSTATE, 3 FIBERS EXHIBITED AN AUDIBLE CLICKING NOISE ORIGINATING FROM THE WORKING END OF THE FIBER TIP WHEN THE CONSOLE'S PEDAL WAS BEING PRESSED. 2 JOULES AND 50 HERTZ HAD BEEN USED DURING PROCEDURE, AND THE ENERGY WAS NOT BEING EMITTED PROPERLY. THE SHEATH THAT SURROUNDED THE FIBERS WAS COMING APART. THE WORKING TIPS OF THE FIBERS WERE ASYMMETRICAL AND BROKEN. HOWEVER, NO FIBER FRAGMENTS WERE SEEN INSIDE THE PATIENT. ALL 3 FIBERS AND THE CONSOLE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO INJURIES TO THE OPERATOR OR PATIENT; THERE WERE NO PATIENT COMPLICATIONS. FIBER 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534734 ↗MalfunctionMar 6, 2026Break; Nonstandard Device; Peeled/Delaminated
IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE TO TREAT AN ENLARGED PROSTATE, 3 FIBERS EXHIBITED AN AUDIBLE CLICKING NOISE ORIGINATING FROM THE WORKING END OF THE FIBER TIP WHEN THE CONSOLE'S PEDAL WAS BEING PRESSED. 2 JOULES AND 50 HERTZ HAD BEEN USED DURING PROCEDURE, AND THE ENERGY WAS NOT BEING EMITTED PROPERLY. THE SHEATH THAT SURROUNDED THE FIBERS WAS COMING APART. THE WORKING TIPS OF THE FIBERS WERE ASYMMETRICAL AND BROKEN. HOWEVER, NO FIBER FRAGMENTS WERE SEEN INSIDE THE PATIENT. ALL 3 FIBERS AND THE CONSOLE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO INJURIES TO THE OPERATOR OR PATIENT; THERE WERE NO PATIENT COMPLICATIONS. FIBER 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534584 ↗MalfunctionMar 2, 2026Break; Nonstandard Device; Peeled/Delaminated
IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE TO TREAT AN ENLARGED PROSTATE, 3 FIBERS EXHIBITED AN AUDIBLE CLICKING NOISE ORIGINATING FROM THE WORKING END OF THE FIBER TIP WHEN THE CONSOLE'S PEDAL WAS BEING PRESSED. 2 JOULES AND 50 HERTZ HAD BEEN USED DURING PROCEDURE, AND THE ENERGY WAS NOT BEING EMITTED PROPERLY. THE SHEATH THAT SURROUNDED THE FIBERS WAS COMING APART. THE WORKING TIPS OF THE FIBERS WERE ASYMMETRICAL AND BROKEN. HOWEVER, NO FIBER FRAGMENTS WERE SEEN INSIDE THE PATIENT. ALL 3 FIBERS AND THE CONSOLE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO INJURIES TO THE OPERATOR OR PATIENT; THERE WERE NO PATIENT COMPLICATIONS. FIBER 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491643 ↗InjuryFeb 20, 2026Break; Overheating of Device
IT WAS REPORTED THAT, DURING A PROCEDURE, A MOSES LASER FIBER BURNED THROUGH ITS OWN FIBER WHILE IN USE, RESULTING IN A BURN INJURY IN THE PHYSICIAN THUMB WHICH REQUIRED NO TREATMENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT FIBER. THE PHYSICIAN IS EXPECTED TO MAKE A FULL RECOVERY, AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Burn(s)
MAUDE report 24401750 ↗MalfunctionFeb 17, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT CUSTOMER EMAILED THAT THE FIBER TIP FELL OFF PRIOR TO USING IT. THEY USED A NEW FIBER TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24371162 ↗MalfunctionFeb 16, 2026Nonstandard Device
IT WAS REPORTED THAT THE FIBER WAS RETURNED WITHOUT INITIAL REPORTER AND PERFORMANCE ALLEGATION INFORMATION. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24348589 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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