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

Model Number	GA-0008800
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for the procedure, the console system did not start.The patient was on the table waiting when the device issue occurred.It was noted that the power socket, on off switch, key, and emergency button were all checked and found to be functioning properly.As a result, it was determined the console needed to be checked.The procedure was cancelled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The investigation confirmed that the system failed to power up before the procedure, resulting in the procedure being cancelled with no patient complications.Service evaluation identified a broken ac board, and after the ac controller was replaced, the unit operated normally and met specifications.A risk review determined that this failure mode is already known and documented within the product risk management file, and related impacts such as procedure cancellation are considered secondary and not device related.The labeling review confirmed that the ifu provides appropriate instructions for troubleshooting power up issues and that no misuse or labeling concerns contributed to the event.Because the malfunction was traced to an expected or random component failure with no design or manufacturing issues identified, the investigation conclusion code assigned is cause traced to component failure.The following fields were corrected e3.Initial reporter, g2.Report source.
Event or Problem Description
It was reported that, prior to the procedure, the system did not start while the patient was already on the table awaiting treatment.The power socket, on/off switch, key switch, and emergency stop button were checked and confirmed to be functioning properly.As the issue could not be resolved through initial troubleshooting, the console required further evaluation.The procedure was cancelled.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status 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: 24259402
• Report Number: 2124215-2026-06016
• Device Sequence Number: 13155428
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: (01)07290109145419(11)200520(10)120
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown