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

Model Number	GA-1008944
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to holmium laser enucleation of the prostate procedure the equipment display was frozen after being turned on and the system did not work.When turned the key on cannot hold the ac control the system.The procedure was cancelled, there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that prior to holmium laser enucleation of the prostate procedure the equipment display was frozen after being turned on and the system did not work.When turned the key on cannot hold the ac control the system.The procedure was cancelled, there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Boston scientific concludes that the reported performance allegation in this complaint has not been confirmed, as the product was not returned for analysis.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
The central processing unit (cpu) was returned for analysis.During visual inspection was identified that this cpu was in good physical condition and the electrical connections was in good condition too.Therefore, the reported allegation was not confirmed.The investigation was unable to identify any damage or malfunction related to the reported allegation.No evidence was found to indicate a manufacturing or design-related issue.The device history record (dhr) met all material, assembly and performance specifications.A risk review was completed and confirmed that the event of device operates differently than expected and display screen - frozen are known event defined in the risk documentation.Since the investigation findings clearly confirm that there was no problem with the device, the conclusion code selected for the complaint is device problem excluded.
Event or Problem Description
It was reported that prior to holmium laser enucleation of the prostate procedure the equipment display was frozen after being turned on and the system did not work.When turned the key on cannot hold the ac control the system.The procedure was cancelled, there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• Brand Name: 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: 20231328
• Report Number: 2124215-2024-57519
• Device Sequence Number: 8516532
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: 07290109145969
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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-1008944
• Device Catalogue Number: GA-1008944
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 03/03/2026
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/03/2024; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown