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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console had low power.There was no patient involvement.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the fse replaced checked the optical bench and performed functional test and power energies measurement.All values were in specifications.No low power was identified.The debris shield installed in the device upon arrival was suspected to be damaged.The debris shield was replaced, and energies measurement was performed again, and all values were in specifications, and the system is ready for use.It is most likely that the damaged component could have affected the device performance leading to the event experienced by the customer.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).The ifu states: if the external power meter reading falls above or below +-20% of the requested energy on your laser system, discontinue this procedure and contact lumenis customer service.A risk review was completed and confirmed that the event of "low power" was defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console had low power.There was no patient involvement.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 24354992
• Report Number: 2124215-2026-08714
• Device Sequence Number: 15981979
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown