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

Model Number	AC-0020170
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the laser arm was clipping, and when the engineer removed the articulated arm and the cover to the optical bench, it was noticed the aiming and burn beam were out of alignment, the near and far alignment as well.The fse proceeded to perform the laser alignment and the scanner, the new micromanipulator and new joystick replacement and finally, the device passed full functional testing.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely that the defective device led to the reported event.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the aiming and burn beam were out of alignment.There was no patient involved.
Additional Manufacturer Narrative
The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the laser arm was clipping, and when the engineer removed the articulated arm and the cover to the optical bench, it was noticed the aiming and burn beam were out of alignment, the near and far alignment as well.The fse proceeded to perform the laser alignment and the scanner, the new micromanipulator and new joystick replacement and finally, the device passed full functional testing.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely that the defective device led to the reported event.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the aiming and burn beam were 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): 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: 19767983
• Report Number: 2124215-2024-42616
• Device Sequence Number: 8778106
• Product Code: GEX
• UDI-Device Identifier: 07290109141954
• UDI-Public: (01)07290109141954
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: AC-0020170
• Device Catalogue Number: AC-0020170
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown