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

Model Number	AA3042000
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the micromanipulator has alignment issues.There was no patient involved.
Additional Manufacturer Narrative
The console components were not returned for analysis; however, the device was evaluated on site by a field service engineer, who confirmed the reported issue.During the evaluation, it was identified that the digital acublade was not functioning properly.Corrective actions were implemented, including replacement of the micromanipulator and microswitch, resolving the issue.A review of the micromanipulator hazard analysis was completed and confirmed that the event of 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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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, the micromanipulator has alignment issues.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): 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: 24292925
• Report Number: 2124215-2026-07165
• Device Sequence Number: 15990951
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2026

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: AA3042000
• Device Catalogue Number: AA3042000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 08/05/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/24/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown