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

Model Number	GA-0006802
Medical Device Problem Codes	Failure to Align (2522); Material Integrity Problem (2978); Output below Specifications (3004)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure the mirror of this console was misaligned which caused the patient to have post bleeding.No additional information was reported.
Event or Problem Description
It was reported that during procedure the mirror of this console was misaligned which caused the patient to have post bleeding.No additional information was reported.
Additional Manufacturer Narrative
Correction to field e2: health professional.Correction to field h6: device codes.
Additional Manufacturer Narrative
Correction to field b5: describe event or problem correction to field h6: device codes the device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Service history review performed indicates that the console remained fully functional, with no issues reported until the last service and/or complaint date.Based on service records, the issue is more likely due to use-related wear or field conditions rather than manufacturing or design at release.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The blood loss is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.A risk review was completed and confirmed that the events of device - low power and blood loss were defined in the risk documentation and are documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, no problem was detected that contributed to the reported event.Therefore, the conclusion codes of no problem detected and known inherent risk assigned to this investigation.
Event or Problem Description
It was reported that during procedure this console exhibited low power which caused the patient to have post bleeding.No additional information was reported.

• 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: 24713684
• Report Number: 2124215-2026-16819
• Device Sequence Number: 5664616
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)201027(10)59
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-0006802
• Device Catalogue Number: GA-0006802
• Device Lot Number: 0000000059
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/07/2026; 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/08/2026
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male