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

Model Number	GA-0008800
Medical Device Problem Codes	Nonstandard Device (1420); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); 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	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device prompted an error code 240, 78, 252 and case saver after repair and preventative maintenance.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under unknown sedation.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the customer's facility by a field service engineer (fse).The fse confirmed the reported allegation of device displaying an error message, case saver mode and additionally found footswitch issue during service.The fse calibrated the device, the issue was resolved, and the unit was within specifications.A labeling review was performed and there is no indication that the device was not used in accordance with the instructions for use.A risk review was performed and confirmed that the events of cancelled/rescheduled - post sedation/sedation unknown and surgical procedure delayed are known event defined in the product's risk management documentation.The event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It also includes consideration of risk severity and rate, and the overall residual risk of the p120 device is acceptable.The investigation conclusion code assigned is cause traced to component failure, which indicates an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that this device prompted an error code 240, 78, 252 and case saver after repair and preventative maintenance.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under unknown sedation.
Additional Manufacturer Narrative
This report is report is being submitted to correct the description of event or problem (b5) in section b, adverse event/product problem and mfr site zip/post code (g1) in section g, all manufacturers.Upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the customer's facility by a field service engineer (fse).The fse confirmed the reported allegation of device displaying an error message, case saver mode and additionally found footswitch issue during service.The fse calibrated the device, the issue was resolved, and the unit was within specifications.A labeling review was performed and there is no indication that the device was not used in accordance with the instructions for use.A risk review was performed and confirmed that the events of cancelled/rescheduled - post sedation/sedation unknown and surgical procedure delayed are known event defined in the product's risk management documentation.The event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It also includes consideration of risk severity and rate, and the overall residual risk of the p120 device is acceptable.The investigation conclusion code assigned is cause traced to component failure, which indicates an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that this device prompted an error code 240 (system not calibrated), 78 (calibration interrupted in the middle), 252 (lasing and safety-pyro main not equal pyro safe) and case saver after repair and preventative maintenance.The procedure was not completed due to this event.There was no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under unknown sedation.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 22835376
• Report Number: 2124215-2025-57146
• Device Sequence Number: 15912204
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)150910(10)5
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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-0008800
• Device Catalogue Number: GA-0008800
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 02/13/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/03/2025; 02/27/2026
• Date Device Manufactured: 09/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown