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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

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 5 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 2 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 4 reportsApr 2025: 4 reportsMay 2025: 8 reportsJun 2025: 4 reportsJul 2025: 5 reportsAug 2025: 5 reportsSep 2025: 1 reportsOct 2025: 8 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 3 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

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

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