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

Model Number	GA-1000000
Medical Device Problem Codes	Failure to Align (2522); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the micromanipulator experienced a focus and alignment anomaly.No procedure nor patient was involved.
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).The fse adjusted the micromanipulators focusing mechanism and verified alignment and focus length using the microscope.Following these actions, the system was observed operating as expected and confirmed to be fully functional.The originally reported concern was confirmed during this evaluation.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 cause traced to component failure.
Event or Problem Description
It was reported that during preparation, the micromanipulator experienced a focus and alignment anomaly.No procedure nor patient was involved.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24434632
• Report Number: 2124215-2026-10248
• Device Sequence Number: 10227393
• Product Code: GEX
• UDI-Device Identifier: 07290109140292
• UDI-Public: (01)07290109140292(11)230921
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/17/2026

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
• Device Lot Number: 0000002086
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown