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); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate procedure, the console stopped working and displayed the error codes: 258 (lasing and safety-pulse rate high), 223 (swm and safety igbt-swm2 simmer fail), 216 (swm and safety igbt-safety igbt leakage fail) and 283 (safety ok h/w line fail).There were no patient complications, however, the case was not completed due to the event with the console.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate procedure, the console stopped working and displayed the error codes: 258 (lasing and safety-pulse rate high), 223 (swm and safety igbt-swm2 simmer fail), 216 (swm and safety igbt-safety igbt leakage fail) and 283 (safety ok h/w line fail).There were no patient complications, however, the case was not completed due to the event with the console.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
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 performed a physical inspection of the console.The output harness was inspected and the switching module for channel 2 (swm2) was replaced.After changing the swm2 the error codes reported were cleared and the system did not present further issues, thus confirming the reported event, which lead the procedure been unable to finished as planned.Based on the analysis results a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
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 performed a physical inspection of the console.The output harness was inspected and the switching module for channel 2 (swm2) was replaced.The dual pedal, single button foot switch was returned.A visual and conductivity testing was performed.The foot switch assembly was in overall good condition, with minor cosmetic wear such as paint chips and scuffing on the foot guard and bottom plate.All rubber feet were intact, and the cable, strain relief, and connector were in proper working order with clean, straight pins.The pedals and center button operated smoothly and returned to their default positions without issue.Internal inspection confirmed all wires were securely connected, screws were clean and corrosion-free, and all switches passed electrical tests for both normally open and normally closed contacts.Conductivity was verified for each wire from switch to pin.After changing the swm2 the error codes reported were cleared and the system did not present further issues, thus confirming the reported event, which lead the procedure been unable to finished as planned.Based on the analysis results a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate procedure, the console stopped working and displayed the error codes: 258 (lasing and safety-pulse rate high), 223 (swm and safety igbt-swm2 simmer fail), 216 (swm and safety igbt-safety igbt leakage fail) and 283 (safety ok h/w line fail).There were no patient complications, however, the case was not completed due to the event with the console.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• 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): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20956384
• Report Number: 2124215-2024-78739
• Device Sequence Number: 7584179
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)231116(10)1352
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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
• 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: 12/07/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 10/15/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/27/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male