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

Model Number	GA-1008944
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an error code 303, high energy, present and only works up to 12w.The debris shield was replaced, and error still persists.The procedure was able to be completed with the same device at low power with no patient complications this event is being reported for low power.
Event or Problem Description
It was reported that there was an error code 303, high energy, present and only works up to 12w.The debris shield was replaced, and error still persists.The procedure was able to be completed with the same device at low power with no patient complications.This event is being reported for low power.
Additional Manufacturer Narrative
Upon receipt of this device component at our quality assurance laboratory, the component was thoroughly analyzed.A visual inspection was performed and noted that the brick (laser source) was in overall good physical condition.The ends are intact with all screws in place.There was no leakage along the end cap seams.The body was clean, and light shone through the rod.The field service engineer (fse) confirmed the complaint.The simmer printed circuit board (pcb) was replaced, powered on the instrument, and initialized without error.The fse ran calibrations and checked output power, with all values within specifications and meets all boston scientific internal (bsi) specifications.The instrument was returned to the customer for clinical use.As a result, the console was functioning as intended, so the issue was resolved.A device history review (dhr) or service history was performed.The product family p100 was installed on september 6, 2019.The console was fully functional with no issues from that date until the complaint date.The malfunction found could have affected the device's performance leading to the event experienced by the customer.Based on the analysis result, the investigation conclusion code assigned is cause traced to component failure.
Event or Problem Description
It was reported that there was an error code 303, high energy, present and only works up to 12w.The debris shield was replaced, and error still persists.The procedure was able to be completed with the same device at low power with no patient complications.This event is being reported for low power.
Additional Manufacturer Narrative
Update to block g2: report source (customer representative added).Upon receipt of this device component at our quality assurance laboratory, the component was thoroughly analyzed.A visual inspection was performed and noted that the brick (laser source) was in overall good physical condition.The ends are intact with all screws in place.There was no leakage along the end cap seams.The body was clean, and light shone through the rod.Additionally, the returned device showed that the simmer printed circuit board (pcb) was in good physical condition and no functional testing was performed.The field service engineer (fse) confirmed the complaint and states that the simmer (pcb) was defective and required replacement.The simmer (pcb) was replaced, powered on the instrument, and initialized without error.The fse ran calibrations and checked output power, with all values within specifications and meets all boston scientific internal (bsi) specifications.The instrument was returned to the customer for clinical use.As a result, the console was functioning as intended, so the issue was resolved.A device history review (dhr) or service history was performed.The product family p100 was installed on september 6, 2019.The console was fully functional with no issues from that date until the complaint date.The malfunction found could have affected the device's performance leading to the event experienced by the customer.Based on the analysis result, the investigation conclusion code assigned is cause traced to component failure.

• 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): 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: 21657681
• Report Number: 2124215-2025-15950
• Device Sequence Number: 12632540
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)190606(10)288(21)288
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2025

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-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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 10/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/06/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown