MAUDE Adverse Event Report: LUMENIS LTD AcuPulse Duo; Powered Laser Surgical Instrument

Model Number	GA-1000000
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during installation of console, it was noted that the arm alignment was lost.There was no patient involved.
Event or Problem Description
It was reported that during installation of console, it was noted that the arm alignment was lost.There was no patient involved.
Additional Manufacturer Narrative
Correction to field g1: mfr site zip/post code.The device was evaluated during on-site service.The articulated arm was found to be misaligned, confirming the reported allegation.During servicing, the articulated arm was replaced and realigned.The device was then checked, calibrated, and functionally verified.All tested parameters were confirmed to be within specification.Following the repair, the issue was resolved, and the device was functioning as intended.

• 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): Boston Scientific Corporation; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23744852
• Report Number: 2124215-2025-88625
• Device Sequence Number: 12879049
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)240204
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K180597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 08/28/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/13/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown