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

Model Number	AC-1003040
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the laser fiber end began to smell like burning and smoking.The fiber was removed from the console, and it was very hot to the touch.The fiber had detached from the rubber coating and was charred at the end.The procedure was completed with another fiber without patient complications.
Event or Problem Description
It was reported that during the procedure, the laser fiber end began to smell like burning and smoking.The fiber was removed from the console, and it was very hot to the touch.The fiber had detached from the rubber coating and was charred at the end.The physician replaced the fiber, and the procedure was completed with another fiber without patient complications.
Additional Manufacturer Narrative
The device was not available for analysis; therefore, no physical analysis of the product could be performed.The reported device allegation cannot be confirmed.Based on the information available the cause that contributed to the information available the cause that contributed to the reported event cannot be established.

• Brand Name: MOSES LP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21971670
• Report Number: 2124215-2025-27786
• Device Sequence Number: 8503428
• Product Code: GEX
• UDI-Device Identifier: 07290109144566
• UDI-Public: (01)07290109144566(17)280627(10)23083869
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: AC-1003040
• Device Catalogue Number: AC-1003040
• Device Lot Number: 0023083869
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 06/29/2023
• 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