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

Model Number	GA-0000070
Medical Device Problem Codes	Failure to Align (2522); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with a secondary beam, there is a micromanipulator that may need the mirror changing for one with the anti-reflex spot to stop this.And it is believed that it could also be misalignment.Boston scientific has been unable to obtain additional information regarding the patient involvement to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was field service at the user's facility.The optics were checked and cleaned.The alignment out the arm was inspected and was fine.Also, the alignment through the scanner and acuspot were inspected, there were no issues found.In addition, the system was check on microscope with user but, the issue was not present.Therefore, the reported event could not be confirmed.
Additional Manufacturer Narrative
The console was field service at the user's facility.The optics were checked and cleaned.The alignment out the arm was inspected and was fine.Also, the alignment through the scanner and acuspot were inspected, there were no issues found.In addition, the system was check on microscope with user but, the issue was not present.Therefore, the reported event could not be confirmed.
Event or Problem Description
It was reported that during procedure there was an issue with a secondary beam, there is a micromanipulator that may need the mirror to be changed.And it is believed that it could also be misalignment.The procedure was completed.There were no patient complications reported.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21144178
• Report Number: 2124215-2024-83714
• Device Sequence Number: 9134793
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 03/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown