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

Model Number	GA-2006378
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the console showed an error code 240 (ho system not calibrated - detected in user mode on startup that system not calibrated by service/manufacturing before) and 268 (lasing and safety-mmcu sw detected timeout on delivering first pulse).The procedure was not completed due to this event, however, a planned procedure on (b)(6) 2025, was performed, and was completed with another device.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The fse completed visual inspection and noted that the switch module was defective and required replacement; therefore, confirming the complaint.After the fse replaced the switch module the issue was resolved, and the unit was within specifications.The malfunction found could have affected the device performance leading to the event experienced by the customer.The switch module was returned to our quality assurance laboratory and underwent a thorough analysis.Visual inspection found the device in good physical condition.The electrical connections are also in good condition.No function testing was performed.
Event or Problem Description
It was reported that during preparation, the console showed an error code 240 (ho system not calibrated - detected in user mode on startup that system not calibrated by service/manufacturing before) and 268 (lasing and safety-mmcu sw detected timeout on delivering first pulse).The procedure was not completed due to this event, however, a planned procedure on (b)(6) 2025, was performed, and was completed with another device.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation is unknown.

• 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: 21493694
• Report Number: 2124215-2025-12524
• Device Sequence Number: 8423617
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: (01)07290109144665(11)200617(10)34
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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-2006378
• Device Catalogue Number: GA-2006378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown