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

Model Number	GA-1008944
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this unit will not turn on and burn smell coming from unit.No additional information was received.
Additional Manufacturer Narrative
An investigation was initiated; however, the device was not returned for evaluation, and therefore product analysis could not be performed.As a result, the reported allegation could not be confirmed.Service case notes indicated that the customer declined repair.A review of available information showed no evidence of a broader quality concern.The event type is known and accounted for within established risk assessments for this product.Without the device available for inspection, the cause of the reported issue could not be determined, and a device related problem could not be excluded.Based on the investigation, there is no indication that the issue is linked to manufacturing or design, nor does it represent a recurrence or trend requiring further escalation.No additional action beyond the complaint investigation is required at this time.
Event or Problem Description
It was reported that this unit will not turn on and burn smell coming from unit.No additional information was received.

• 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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24240838
• Report Number: 2124215-2026-05897
• Device Sequence Number: 10188322
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: (01)07290109145969(11)161129(10)71
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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-1008944
• Device Catalogue Number: GA-1008944
• Device Lot Number: 0000000071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/22/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/20/2026
• Date Device Manufactured: 11/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown