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	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, anomalies were observed between the laser dot and the adjustment lever, as they were not in the correct positions.These observations were specifically associated with the micromanipulator, as the joystick did not function as expected.The procedure was completed using the original device; however, no details regarding the patient outcome was provided.
Event or Problem Description
It was reported that during preparation, anomalies were observed between the laser dot and the adjustment lever, as they were not in the correct positions.These observations were specifically associated with the micromanipulator, as the joystick did not function as expected.The procedure was completed using the original device; however, no details regarding the patient outcome was provided.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.The device was serviced onsite by a field service engineer (fse).Testing performed by the fse showed that the indicator light and laser beams overlapped correctly, confirming that the equipment was functioning as expected; therefore, the complaint could not be confirmed.A risk review was completed and confirmed that the event of micromanipulator misaligned was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of device problem excluded.

• 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: 24534543
• Report Number: 2124215-2026-12638
• Device Sequence Number: 18734830
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)150906
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 09/06/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown