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

Model Number	GA-2003477
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console was in low output mode.There were no patient complications.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the lens reflecting the laser got burnt causing the device starts up in low output mode.The fse proceeded to replace the #2hr and #3frm.The laser console was finally tested and the device passed full functional testing.No further issues were identified during service, and the console was confirmed to be fully functional after the replacement.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, the console was in low output mode.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: 20570810
• Report Number: 2124215-2024-68135
• Device Sequence Number: 18281690
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: 07290109145440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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-2003477
• Device Catalogue Number: GA-2003477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown