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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 48 displayed during the procedure.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console was serviced onsite by a field service engineer (fse).The error message allegation was confirmed.The fse replaced the laser power unit (lpu), imported the current calibration data and checked for different parts that could be affected by the injury.The issue was solved.Based on the analysis results, the reported ready button unable to be pressed was confirmed as replacing the faulty charger resolved the issue.Due to the massive amount of saline solution in the laser, no guarantee could be made for further failures.No failure of the smart interlock system (sis) antenna was detected.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that error 48 displayed during the procedure.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that error 48 displayed during the procedure.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
Corrected content previously provided in sections h6.Evaluation conclusion codes, and h11.Additional mfr narrative.The console was serviced onsite by a field service engineer (fse).The error message allegation was confirmed.The fse replaced the laser power unit (lpu), imported the current calibration data and checked for different parts that could be affected by the injury.The issue was solved.Based on the analysis results, the reported ready button unable to be pressed was confirmed as replacing the faulty charger resolved the issue.A massive amount of saline solution was found inside the system, and in addition, the saline solution container was located in an inappropriate place inside the room, which most likely led to the event experienced by the customer.Due to the massive amount of saline solution in the laser, no guarantee could be made for further failures.No failure of the smart interlock system (sis) antenna was detected.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).The ifu states: inspect cables and all external surfaces for damage.If damage is found, call lumenis service.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available and analysis results, the interaction between the user and device caused or contributed to the reported error.This includes unintended inappropriate use of the device and incorrect sample preparation.A conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 22750005
• Report Number: 2124215-2025-55272
• Device Sequence Number: 13179766
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 03/20/2026; 04/22/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/30/2025; 04/09/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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