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

Model Number	GA-0008700
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 66 (brick 4 not working case saver mode) and error 150 (fiber not connected) were displayed.The procedure was cancelled because it was a holmium laser enucleation of the prostate (holep) case which requires higher power.There was no patient outcome reported.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 66 (brick 4 not working case saver mode) and error 150 (fiber not connected) were displayed.The procedure was cancelled because it was a holmium laser enucleation of the prostate (holep) case which requires higher power.There was no patient outcome reported.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
B1.Adverse event/product problem: correction.As of today, the above referenced laser console has not been returned.Therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse identified error 66 as the laser was in case saver mode.Brick four was down and the second relay mirror was burnt.Those were replaced and aligned.The blast shield optic was damaged.Therefore, it was replaced.The laser console passed full functional and electrical safety testing.Based on the analysis results, the reported clinical observations were confirmed as replacing the relay mirror, the brick and the blast shield resolved the issues.These damaged parts are most likely the reason that caused the device performance leading to the reported error messages.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that error 66 (brick 4 not working case saver mode) and error 150 (fiber not connected) were displayed.The procedure was cancelled because it was a holmium laser enucleation of the prostate (holep) case which requires higher power.There was no patient outcome reported.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• 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: 21403756
• Report Number: 2124215-2025-09151
• Device Sequence Number: 8524170
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)230316(10)108(21)108
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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-0008700
• Device Catalogue Number: GA-0008700
• Device Lot Number: 0000000108
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/06/2025; 04/16/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/26/2025; 05/06/2025
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown