MAUDE Adverse Event Report: LUMENIS LTD. MOSES¿; POWERED LASER SURGICAL INSTRUMENT

Model Number	MOSES¿ 365 D\F\L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: MOSES¿
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 22992142
• Report Number: 22992142
• Device Sequence Number: 15819935
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/30/2025

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
• Device Model Number: MOSES¿ 365 D\F\L
• Device Catalogue Number: AC-10030110
• Device Lot Number: 14632411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/30/2025