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

Model Number	GA-0000070
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, it was found that the aiming light and the laser did not overlap.However, it was confirmed that the aiming beam was along the direction with the laser, and the aiming beam was dim.The procedure was completed with the same device.There were no patient complications reported.Field services of the console identified that the laser and aiming beam alignment needed to be adjusted.
Additional Manufacturer Narrative
The console was field service at the user's facility, the alignment of the laser and aiming light of the console were adjusted.After performing the adjustment, the overlap of the laser and aiming light, was tested and function was normal.Therefore, the reported event was confirmed.

• Brand Name: ACUPULSE
• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22308438
• Report Number: 2124215-2025-40757
• Device Sequence Number: 8706088
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)160503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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-0000070
• Device Catalogue Number: GA-0000070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 05/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown