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

Model Number	GA-0006902
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser enucleation of prostate, the console prompted error code 188 (cooling system error cooling flow switch error).As a result, the procedure was cancelled.There were no reported patient complications.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
There was no device available for analysis.Therefore, no physical or visual analysis of the product could be performed.However, the console was serviced onsite by a field service engineer (fse) and replaced the cooling system fuse component thus resolving the issue with the console.A review of the device history record showed that the console was installed on 04oct2023.After this period, some component wear is possible based on product use.Based on the information available, it is probable that the fuse component contributed to the performance of the console which led to the procedure being re-scheduled.After replacement of the fuse, the unit was within specification, and the console was functioning as intended.
Event or Problem Description
It was reported that during a holmium laser enucleation of prostate, the console prompted error code 188 (cooling system error-cooling flow switch error).As a result, the procedure was cancelled.There were no reported patient complications.This event is being reported for aborted/canceled 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): BOSTON SCIENTIFIC CORPORATION; yokneam industrial park; park hakidma st. 6; yokneam
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21405732
• Report Number: 2124215-2025-08460
• Device Sequence Number: 15507747
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)230906(10)1237(21)1237
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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-0006902
• Device Catalogue Number: GA-0006902
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown