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

Model Number	GA-1000000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foot pedal keeps getting stuck.No further information was provided.
Event or Problem Description
It was reported that the foot pedal keeps getting stuck.No further information was provided.
Additional Manufacturer Narrative
The console was field serviced at the user's facility.During service repair, the foot pedal was replaced.After the replacement of foot pedal, the issue was resolved and the console was functioning as intended.Service history review was completed and identified that the device was installed on (b)(6) 2014, and this event occurred 11 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and confirmed that the event of foot switch pedal stuck in on position 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 available information, the reported event was confirmed as the foot pedal had to be replaced, therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: ACUPULSE DUO
• 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: 24491798
• Report Number: 2124215-2026-11554
• Device Sequence Number: 5092470
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)140512
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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-1000000
• Device Catalogue Number: GA-1000000
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 05/12/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown