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	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the device showed low power while lasing, although no error appeared on the screen.No further information was provided.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse inspected the system optics and verified optical alignment, with all findings acceptable.System calibration was performed, and all parameters were within specification.The fse conducted functional testing across multiple power settings using a long test fiber and verified power output measurements with a power meter in the presence of the hospital technician.All tests were passed, and the system was confirmed to be fully operational.The complaint was not confirmed.A risk review was completed and confirmed that the event of low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on all the available information objective evidence from the product analysis being unable to confirm the reported complaint, this investigation is being assigned a conclusion code of no problem detected.Therefore, the manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the initially reported low power.
Event or Problem Description
It was reported that during preparation, the device showed low power while lasing, although no error appeared on the screen.No further information was provided.

• 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: 24552622
• Report Number: 2124215-2026-13003
• Device Sequence Number: 9404617
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)220119(10)545
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown