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

Model Number	AA3042000
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the micromanipulator is out of alignment.There was no patient involved.
Additional Manufacturer Narrative
The device was not returned for analysis.However, the device was serviced by a field service engineer (fse) onsite.The fse examined the console and micromanipulator.The fse found that the aiming beam and treatment beam coincidence was very slightly off.The console's aiming beam and treatment beam were adjusted; however, this did not resolve the issue.The micromanipulator was examined further and it was found that the dichroic mirror had been reglued upside down by the customer.This was causing the treatment beam to coincide with the reflection of the aiming beam instead of the aiming beam dot itself.The dichroic mirror was replaced on the micromanipulator, and the issue was resolved.The treatment beam was now coincident with the aiming beam.The coolant level was then checked, aiming and treatment beam coincidence was verified, and it was verified that the energy output at all levels was checked.The system was ready to be used.The instructions for use state: beam alignment checks are extremely important for the safe operation of your laser equipment.Do not use the laser or delivery system if aiming and treatment beams are not coincident; call your local lumenis representative.Misalignment of aiming and treatment beams may result in laser exposure to non-target tissues and possible injury.Based on the analysis results, the reported misalignment was due to the customer regluing the dichroic mirror upside down.
Additional Manufacturer Narrative
The device was not returned for analysis.However, the device was serviced by a field service engineer (fse) onsite.The fse examined the console and micromanipulator.The fse found that the aiming beam and treatment beam coincidence was very slightly off.The console's aiming beam and treatment beam were adjusted, however this did not resolve the issue.The micromanipulator was examined further and it was found that the dichroic mirror had been reglued upside down by the customer.This was causing the treatment beam to coincide with the reflection of the aiming beam instead of the aiming beam dot itself.The dichroic mirror was replaced on the micromanipulator, and the issue was resolved.The treatment beam was now coincident with the aiming beam.The coolant level was then checked, aiming and treatment beam coincidence was verified, and it was verified that the energy output at all levels was checked.The system was ready to be used.The instructions for use state: beam alignment checks are extremely important for the safe operation of your laser equipment.Do not use the laser or delivery system if aiming and treatment beams are not coincident; call your local lumenis representative.Misalignment of aiming and treatment beams may result in laser exposure to non-target tissues and possible injury.In addition, the micromanipulator mirror was returned for visual inspection.The hinged was attached to the mirror and no abnormalities were found.Based on the analysis results, the reported misalignment was due to the customer regluing the dichroic mirror upside down.
Event or Problem Description
It was reported that the micromanipulator is out of alignment.There was no patient involved.

• Brand Name: ACUSPOT
• 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: 21827883
• Report Number: 2124215-2025-23058
• Device Sequence Number: 9280980
• Product Code: GEX
• UDI-Device Identifier: 07290109141916
• UDI-Public: (01)07290109141916(11)240715(10)4568
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: Other
• Device Model Number: AA3042000
• Device Catalogue Number: AA3042000
• Device Lot Number: 0000004568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown