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Moses™ AC-10030100Recalls & reported problems

Lumenis Ltd. · Moses 200 D/F/L · Class 2

Quick summary

This Moses holmium laser from Lumenis is used in kidney stone procedures. The FDA database holds 548 reports for it, most describing laser fibers that break during ureteroscopy, and some mentioning burns to patients or staff. There were 55 injuries and no deaths. 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
532
Deaths reported
0
Injuries reported
54
Recalls naming it
0

Summary

The FDA's MAUDE database contains 532 adverse event reports that list this exact device (DI 07290109143170), received between Jan 20, 2019 and Sep 30, 2026 — classified as 54 injuries, 478 malfunctions.

The most frequently reported specific device problem is “Break” (387 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.

Reports received per month

Nov 2023: 7 reportsDec 2023: 7 reportsJan 2024: 5 reportsFeb 2024: 4 reportsMar 2024: 5 reportsApr 2024: 4 reportsMay 2024: 11 reportsJun 2024: 6 reportsJul 2024: 6 reportsAug 2024: 11 reportsSep 2024: 10 reportsOct 2024: 7 reportsNov 2024: 13 reportsDec 2024: 7 reportsJan 2025: 5 reportsFeb 2025: 24 reportsMar 2025: 23 reportsApr 2025: 20 reportsMay 2025: 21 reportsJun 2025: 20 reportsJul 2025: 23 reportsAug 2025: 27 reportsSep 2025: 19 reportsOct 2025: 22 reportsNov 2025: 26 reportsDec 2025: 18 reportsJan 2026: 9 reportsFeb 2026: 14 reportsMar 2026: 15 reportsApr 2026: 17 reportsMay 2026: 2 reportsJun 2026: 15 reportsJul 2026: 7 reportsAug 2026: 15 reportsSep 2026: 11 reportsOct 2026: 0 reports20242025202627
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break387
  • Adverse Event Without Identified Device or Use Problem56
  • Defective Device51
  • Nonstandard Device30
  • Power Problem24
  • Material Integrity Problem22
  • Connection Problem9
  • Separation Problem8

Patient problems

  • No Clinical Signs, Symptoms or Conditions457
  • Burn(s)46
  • Insufficient Information8
  • No Known Impact Or Consequence To Patient7
  • Foreign Body In Patient4
  • Superficial (First Degree) Burn3
  • No Consequences Or Impact To Patient2
  • Perforation2

Recent adverse event reports

The 25 most recent of 532 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 50952630 ↗
  • MalfunctionSep 30, 2026Material Integrity Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50950016 ↗
  • MalfunctionSep 30, 2026Nonstandard Device; Material Integrity Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50949573 ↗
  • MalfunctionSep 29, 2026Optical Problem; Output Problem; Noise, Audible

    During operation of moses laser staff noticed a "popping" and "cracking" sound. It was also noted the aiming beam was automatically turned off. The laser fiber was replaced, and the laser blast shield was changed. Laser fiber saved for materials management and blast shield given to plant ops. Patient was monitored. Supervisor notified.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50927375 ↗
  • MalfunctionSep 28, 2026Overheating of Device

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50926219 ↗
  • MalfunctionSep 28, 2026Break

    It was reported that during a lithotripsy procedure, the fiber broke during use. The procedure was completed with another fiber without patient complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50915004 ↗
  • MalfunctionSep 22, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50862325 ↗
  • MalfunctionSep 17, 2026Material Integrity Problem

    It was reported that during the pre-use check, the fiber was found to be unusable. Another lot of the device was used to complete the procedure. There was no patient complication. After that, the fiber was returned for analysis and the microscope inspection found that the fiber connector had distorted light exiting the face, indicating an internal connector fracture.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50806120 ↗
  • MalfunctionSep 17, 2026Break

    It was reported that during procedure, the fiber broke at the glass tip. The physical fractured of the fiber could not be confirmed but a cracked was heard. The procedure was completed as it was able to basket out the rest of the stones after the fiber broke. There were no patient complications. Customer mentions that this has been a recurrent issue with fibers of 200 micrometers. In the past the fibers were replaced for a different lot number to see if that could be contributing to the issue. The console settings were checked during visit, and they were set correctly.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50802104 ↗
  • MalfunctionSep 10, 2026Break

    It was reported that during a procedure, the fiber broke it was notices that no aiming beam or power was hitting the stone and when pulling out the fiber it was noticed that the broken piece was still inside, the part was retrieved using a basket. The procedure was completed by replacing the fiber without patient complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50713625 ↗
  • MalfunctionSep 4, 2026Break

    It was reported that post procedure/prior to discharge, the fibers were broken in the middle of the fiber after use. The procedure was completed with this device. There was no patient involvement at the time the issue was presented.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50601135 ↗
  • MalfunctionAug 31, 2026Break

    It was reported that the fiber broke in the middle of the ureteroscopy procedure. The procedure was completed with another device. There were no patient complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50526922 ↗
  • MalfunctionAug 24, 2026Break; Overheating of Device

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50420738 ↗
  • MalfunctionAug 21, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50370184 ↗
  • MalfunctionAug 20, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50360051 ↗
  • MalfunctionAug 19, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50331350 ↗
  • MalfunctionAug 18, 2026Break

    It was reported that during a Ureteroscopy with Laser Lithotripsy procedure to treat Kidney Stones, the fiber broke. The case was completed with a different fiber. No patient complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50290610 ↗
  • MalfunctionAug 17, 2026Break; Nonstandard Device

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50288830 ↗
  • InjuryAug 17, 2026Break

    It was reported that during preparation prior to a procedure, the surgeon received a burn in the left index finger after the fiber broke outside of the scope while operating the holmium laser. The patient was unharmed, ureteroscopy with laser for fragmentation of kidney stone was being performed. Further information stated that the doctor was operating the Holmium laser when the fiber broke, the event of the fiber break might have been from the tension applied on it since this one goes over the patient with a wet hand towel to secure. The patient was unharmed and the physician's burn was rinsed with cold saline; the doctor changed his gloves to new ones and proceeded with the case. Another fiber was opened to proceed but also got broken, therefore a third fiber was used to finish the case. No further details were provided despite good faith efforts.

    Patient problems: Burn(s)

    MAUDE report 50288827 ↗
  • MalfunctionAug 17, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50288825 ↗
  • MalfunctionAug 17, 2026Break

    It was reported that during a Ureteroscopy with laser lithotripsy procedure, the fiber broke. The procedure was completed with another fiber without patient complications.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50288823 ↗
  • MalfunctionAug 17, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50284720 ↗
  • InjuryAug 14, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

    MAUDE report 50256084 ↗
  • MalfunctionAug 12, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228404 ↗
  • MalfunctionAug 4, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50128433 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.