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

Model Number	GA-1008942
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power of this device was lower than usual when shooting.There were no report of patient or procedure involved.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The device was not returned for analysis; however, the reported low power was confirmed by a field service engineer (fse).Inspection was performed and found that the blast shield was defective.The blast shield was replaced, optical inspection was performed on all four channels, functional test was performed and no errors.Electrical safety test was performed.Checklist passed and laser is operating according to boston scientific's specifications.The malfunctioned found could have affected the device performance leading to the event experienced by the customer.A review of the device instructions for use (ifu) was performed and stated that the reported patient effect of low power was listed in the ifu as potential outcome of this procedure.There is no indication that the device was not used in accordance with the ifu.A device history review (dhr) was performed and confirmed that the device was installed on 5/9/2019 and this event occurred 6 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation indicating that an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that the power of this device was lower than usual when shooting.There were no report of patient or procedure involved.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 23420575
• Report Number: 2124215-2025-77877
• Device Sequence Number: 9863391
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)190127(10)211
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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-1008942
• Device Catalogue Number: GA-1008942
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 01/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown