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

Model Number	GA-0008800
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, there was smoke development.The procedure was completed with the original device without patient complications.
Event or Problem Description
It was reported that during a procedure, there was smoke smell development coming from the debris shield.The procedure was completed with the original device without patient complications.
Event or Problem Description
It was reported that during a procedure, there was smoke smell development coming from the debris shield.The procedure was completed with the original device without patient complications.
Additional Manufacturer Narrative
Based on the information gathered from customer, the account had issues with burned fibers and debris shield.After, replaced both components the user could keep working.The malfunction found could have affected the device performance leading to the reported event of smoking, therefore, the initial allegation was confirmed.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21677027
• Report Number: 2124215-2025-17527
• Device Sequence Number: 20756444
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)191226(10)111
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: GA-0008800
• Device Catalogue Number: GA-0008800
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 06/18/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/10/2025; 07/10/2025
• Date Device Manufactured: 12/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown