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

Model Number	GA-0000070
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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a misalignment between the console and the aiming beam.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console was inspected, and it was identified that the aiming beam was misaligned due to a misalignment of the aiming diode and arm.The irradiation position was adjusted.After performing the adjustment, the console was within specification and working as intended.Therefore, the reported event of aiming beam misalignment was confirmed.
Event or Problem Description
It was reported that there was a misalignment between the console and the aiming beam.There was no patient involved.

• 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: 22502482
• Report Number: 2124215-2025-46990
• Device Sequence Number: 18329264
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: (01)07290109140308(11)150602
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 06/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown