MAUDE Adverse Event Report: Lumenis Ltd Lumenis Moses 200 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: Lumenis Moses 200 D\F\L
• Common Device Name: powered laser surgical instrument
• Manufacturer (Section D): Lumenis Ltd; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50802104
• Report Number: 2124215-2026-49626
• Device Sequence Number: 8652983
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: (01)07290109143170(17)281201(10)12792604
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0012792604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown