Moses™ Moses™ 365 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 is a surgical laser used to treat kidney stones. Of its 83 reports, 75 are malfunctions and 8 are injuries, with no deaths. Most describe the laser fiber breaking during procedures, sometimes leaving fragments in the kidney, and a few describe burns. Reports fell to 14 in the last 12 months from 44 in the prior 12 months. 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
- 82
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 07290109143408), received between Jan 20, 2019 and Sep 21, 2026 — classified as 7 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Break” (67 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
- Break67
- Adverse Event Without Identified Device or Use Problem9
- Defective Device3
- Power Problem3
- Use of Device Problem3
- Failure to Deliver Energy2
- Nonstandard Device2
- Thermal Decomposition of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- Burn(s)4
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding1
- Internal Organ Perforation1
- No Consequences Or Impact To Patient1
- Pain1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Thermal Decomposition of Device; Nonstandard Device
It was reported that during a procedure, there was a noise and the fiber blew up. The procedure was completed without patient complications by replacing the fiber. Product analysis of the returned device identified a fracture at the fiber cap/tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848464 ↗MalfunctionSep 9, 2026Break; Thermal Decomposition of Device
It was reported that during an ureteroscopy procedure to treat kidney stone, the fiber was plugged in, and the surgeon was firing on the stone when the tip of the fiber broke off. The procedure was completed using another fiber of the same model. There was no patient complication.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699658 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308218 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308216 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308184 ↗MalfunctionJul 13, 2026Break
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE IN THE MIDDLE OF THE CASE. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791936 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A PIECE OF GLASS IDENTIFIED AS THE FIBER TIP WAS OBSERVED IN THE KIDNEY. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145187 ↗MalfunctionApr 15, 2026Connection Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE DID NOT DETECT THE FIBER AND DID NOT TIGHTEN PROPERLY WHEN SCREWED IN. IT WAS ALSO NOTED THAT THE FIBER HAD A DETACHMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891826 ↗MalfunctionMar 20, 2026Power Problem
IT WAS REPORTED THAT DURING AN URETEROLITHOTOMY PROCEDURE, THERE WAS NO ENERGY, AND THE FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION CONCLUDE THE CONNECTOR HAD NO LIGHT EXITING THE FACE, INDICATING AN INTERNAL CONNECTOR FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651065 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE TO TREAT KIDNEY STONES, THE SCRUB TECH OBSERVED GREEN LIGHT COMING THROUGH THE FIBER BODY WHEN THE CONSOLE'S PEDAL WAS STEPPED ON. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300382 ↗MalfunctionDec 15, 2025Power Problem; Power Problem
IT WAS REPORTED THAT THE FIBER WAS MAKING A SNAPPING SOUND WHEN ACTIVATED AND IT ALSO SCREWED DURING THE URETEROSCOPY PROCEDURE. THE FIBER STOPPED FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER INDICATED THAT THERE WAS AN INTERNAL CONNECTOR FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809696 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN URETEROSCOPY, THE PHYSICIAN WAS INJURED IN HIS HANDS BY THE FIBER. THE BURN WAS LOCATED ON THE HAND NEAR THE WRIST AND WAS CONSIDERED MILD SEVERE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. ALSO, AN ADDITIONAL INTERVENTION WAS REQUESTED.
Patient problems: Burn(s)
MAUDE report 23696728 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE FOR KIDNEY STONES, THE FIBER BROKE AT HALF THE LENGTH. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23518834 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT DURING ENUCLEATION, THE FIBER WAS FRACTURED DISTALLY WHEN THE PEDAL WAS ACTIVATED. IT WAS NOTED THAT THE BREAK OCCURRED IN THE SEGMENT THAT WAS ENTIRELY WITHIN THE WORKING ELEMENT. THE FIBER WAS SUCCESSFULLY TRIMMED, AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441624 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENUCLEATION OF THE PROSTATE PROCEDURE, THE FIBER WORKING ELEMENT FRACTURED DISTALLY WHEN THE PHYSICIAN ACTIVATED THE ENUCLEATION PEDAL. THE PHYSICIAN TRIMMED THE FIBER TIP SUCCESSFULLY AND PROCEEDED TO COMPLETE THE PROCEDURE WITH THE SAME FIBER WITHOUT PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420645 ↗MalfunctionOct 28, 2025Break; Gas Output Problem; Defective Device; Material Integrity Problem; Break; Gas Output Problem; Defective Device; Material Integrity Problem
IT WAS REPORTED THAT DURING PROCEDURE THE GREEN PLASTIC WAS COMING OFF THE TIP. LESS ENERGY WAS NOTICED. THERE WAS FIBER TIP DEGRADATION AND FRAYING. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408353 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT DURING PROCEDURE THE FIBER BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404729 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE OFF AT THE TIP INSIDE A PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352447 ↗InjuryOct 20, 2025Break; Break
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE AND BURNED THE PATIENT SOMEWHERE NEAR ABDOMEN. THE CASE WAS COMPLETED WITH ANOTHER FIBER. THE BURN WAS TREATED WITH BACITRACIN, AND IT WAS CONSIDERED A SEVERE MILD BURN.
Patient problems: Burn(s)
MAUDE report 23343077 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT PRIOR THE PROCEDURE FOR URETHRAL STONES, IT WAS NOTICED THE FIBER WAS CRACKED UPON SCREWING IN THE FIBER, IT WAS VISIBLE WHEN IT WAS PLUGGED INTO THE CONSOLE. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327686 ↗MalfunctionOct 16, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO TREAT BLADDER STONES, THE FIBER BROKE IN THE MIDDLE AFTER APPROXIMATELY 10 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319131 ↗MalfunctionSep 8, 2025Break
DURING URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, MOSES LASER FIBER BROKE. NO HARM TO PATIENT AS IT BROKE WHILE OUTSIDE OF PATIENT. UNABLE TO IDENTIFY ANY USER ERROR. SWAPPED OUT WITH NEW LASER FIBER TO RESUME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992142 ↗MalfunctionAug 28, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Power Problem; Defective Device; Adverse Event Without Identified Device or Use Problem; Power Problem
IT WAS REPORTED THAT THE FIBER HAD A DEFECT AND STOPPED WORKING DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS ANALYZED IN THE LABORATORY, AND IT WAS IDENTIFIED THAT THE FIBER BODY WAS BROKEN IN ADDITION TO THE FIBER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911415 ↗MalfunctionAug 22, 2025Break; Nonstandard Device; Break; Nonstandard Device
IT WAS REPORTED THAT DURING PROCEDURE, SHORTLY AFTER FIRING THE LASER, THE FIBER BROKE AND IT WAS UNUSABLE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873540 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, AFTER THE FIBER WAS TAKEN OUT OF THE PACKAGING AND UPON CONNECTING THE FIBER IT BROKE IN THE MIDDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806944 ↗
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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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