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

Model Number	GA-0006801
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, the physician was having a hard time cutting the tissue, suggesting the console was delivering less power.No error codes were displayed.The procedure was completed with the same device.There were no patient complications.
Additional Manufacturer Narrative
This console was serviced at the customers site.The reported low power allegations were confirmed.The lens cells assembly was replaced as it was not performing as intended, resolving the issue.Further inspection of the console was performed, and no other adjustments were needed.The console is ready for clinical use.The investigation conclusion code assigned is caused traced to component failure as an expected or random component failure without any design damage or manufacturing issue was identified.
Event or Problem Description
It was reported that, during a procedure, the physician was having a hard time cutting the tissue, suggesting the console was delivering less power.No error codes were displayed.The procedure was completed with the same device.There were no 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; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20669520
• Report Number: 2124215-2024-70897
• Device Sequence Number: 17951613
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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-0006801
• Device Catalogue Number: GA-0006801
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown