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	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the optic was found blown resulting in low power output.The console is not used to treat patients but is used for test only.
Event or Problem Description
It was reported that the optic was found blown resulting in low power output.The console is not used to treat patients but is used for test only.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The relay mirror was found to be defective which was replaced by the fse.Service history review performed indicated that the console's installation and functional verification were performed on (b)(6) 2017, system last service performed was on (b)(6) 2025, the console remained fully functional, with no issues reported until the last service and/or complaint date.Based on service records, the issue is more likely due to use-related wear or field conditions rather than manufacturing or design at release.A risk review was completed and confirmed that the event of low power was defined in the risk documentation and is documented accordingly in the product record review (prr).This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The malfunction found could have affected the device performance leading to the event experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue, boston scientific has assigned a conclusion code of cause traced to component failure to this investigation.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24689561
• Report Number: 2124215-2026-15942
• Device Sequence Number: 9976844
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)150820(10)1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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-1008942
• Device Catalogue Number: GA-1008942
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 08/20/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown