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	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an alignment issue with the console, as when use it, it fired off target.The case was cancelled and there was no patient involved at the moment of the event.
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.The console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and it was found that laser aiming beam and laser were not matching.The fse performed an alignment and adjustment of the tube alignment near and far, as long as the console arm.The optics and mirror were checked and cleaned.After the alignment performed the problem was resolved, thus, confirming the reported event.The malfunction found could have affected the device performance leading to the event experienced by the customer.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that there was an alignment issue with the console, as when use it, it fired off target.The case was cancelled and there was no patient involved at the moment of the event.

• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23133777
• Report Number: 2124215-2025-63827
• Device Sequence Number: 15774159
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)140622
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/02/2025

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: 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: 09/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 06/22/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown