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

Model Number	GA-0006902
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console pretest was performed successfully, then the console was turned off.After approximately 30 minutes, the laser was turned on with the key in the off position, the console was switched off and rebooted.Then, smoke and a burning chemical smell were noticed.The laser was not fired, and no errors were recorded.The procedure was completed successfully with an alternate device.There were no patient complications.
Event or Problem Description
It was reported that the console pretest was performed successfully, then the console was turned off.After approximately 30 minutes, the laser was turned on with the key in the off position, the console was switched off and rebooted.Then, smoke and a burning chemical smell were noticed.The laser was not fired, and no errors were recorded.The procedure was completed successfully with an alternate device.There were no patient complications.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The fse found a chemical acidic deposit under the startup capacitor in the chiller.The chemical acidic deposit was identified during the console repair likely contributed to the as reported console burning chemical smell and smoke.The chiller was replaced, and the console passed full functional and electrical safety testing.The console was then ready for use.

• 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20925588
• Report Number: 2124215-2024-76351
• Device Sequence Number: 5043162
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 02/17/2025

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-0006902
• Device Catalogue Number: GA-0006902
• Device Lot Number: 0000001547
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown