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

Model Number	GA-1000000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before the procedure, it was found out that the aiming beam was misaligned by minus 1 mm to minus 1.5 mm.There was no patient involvement.
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 fse set up the laser with the micromanipulator and scanner with the customer, and performed testing.The fse identified the issue was possibly due to the focus setting in the micromanipulator.It is a user setting and needs to be adjusted based on working distance and focus.This has been communicated to the user and also a video explaining this has been sent to the user.The laser console passed full functional and electrical safety testing.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that before the procedure, it was found out that the aiming beam was misaligned by minus 1 mm to minus 1.5 mm.There was no patient involvement.

• Brand Name: ACUPULSE DUO
• 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: 23073039
• Report Number: 2124215-2025-60919
• Device Sequence Number: 15968799
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)220912
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: Other
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown