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

Model Number	GA-0006900
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console kept firing even when the pedal was not pressed.There was no report of any patient complications.
Additional Manufacturer Narrative
The console was not returned for analysis; however, the reported foot switch pedal stuck in on position was confirmed.A service repair was performed on site by the field service engineer (fse).The lumenis crashed and showed use laser mode when run the patient.The machine was restarted, and the system was running normal and a functional test performed and passed.The blast shield mirror was replaced, and replacement for lpu (lumenis computer) and hard disk was suggested.The system was re-calibrated by the field service engineer (fse) and the issue was resolved.The unit was within specification.The malfunction found could have affected the device performance leading to the event experienced by the customer.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console kept firing even if the pedal was not pressed.The procedure was completed with the original device.There were no report of patient complications.
Additional Manufacturer Narrative
The console was not returned for analysis; however, the reported foot switch pedal stuck in on position was confirmed.A service repair was performed on site by the field service engineer (fse).The lumenis crashed and showed use laser mode when run the patient.The machine was restarted, and the system was running normal and a functional test performed and passed.The blast shield mirror was replaced, and replacement for lpu (lumenis computer) and hard disk was suggested.The system was re-calibrated by the field service engineer (fse) and the issue was resolved.The unit was within specification.The malfunction found could have affected the device performance leading to the event experienced by the customer.Additionally, optic blast shield damaged and lpu board damaged was added to the coding table according to the issues found during the service.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console kept firing even if the pedal was not pressed.The procedure was completed with the original device.There were no report of patient complications.

• 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: 21484214
• Report Number: 2124215-2025-12342
• Device Sequence Number: 3956884
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402(11)190822(10)45-305
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 09/02/2025

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-0006900
• Device Catalogue Number: GA-0006900
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 08/04/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 06/13/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown