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	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was not shooting straight, and it is misaligned.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility, visual inspection was performed for all optics and mirror, no issues were identified.The optics and mirrors were cleaned.Aiming beam and treatment beam out of the concentric were verified and it passed all testing.The scanner and micromanipulator were connected to the console, and all shapes were showing a double image vertically.When the micromanipulator is removed, the scanner projects the images correctly and within specification as per the service manual.The micromanipulator needs to be replaced.Therefore, the reported event was confirmed.
Additional Manufacturer Narrative
The console was field service at the user's facility, the system was powered on with no issues.The system passed all initial self-testing.There were no errors found upon start up.Visual inspection was performed for all optics and mirrors, no issues were identified.The optics and mirrors were cleaned.Aiming beam and treatment beam out of the concentric were verified and it passed all testing.The scanner and micromanipulator were connected to the console, and all shapes were showing a double image vertically.When the micromanipulator is removed, the scanner projects the images correctly and within specification per the service manual.A new micromanipulator with the original scanner were connected to the console, but the double image is still present.Upon further troubleshoot, it was noticed that there was only one treatment beam, and it is concentric with the primary beam coming out of the scanner and micromanipulator set up when firing.The double beam is found to be a beam that is cast from dichroic mirror with no treatment beam married to it.These findings are within normal functionality threshold of the console with the scanner and micromanipulator set up connected.Therefore, the reported allegation was not confirmed.Also, it was verified that the treatment beam and aiming beam were concentric out of the mast and arm.It was verified that the optics bench was aligned properly per service manual.All safety features on the system were verified and are functioning correctly per service manual.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the console was not shooting straight, and it is misaligned.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: 21459905
• Report Number: 2124215-2025-10349
• Device Sequence Number: 7642250
• Product Code: GEX
• UDI-Device Identifier: 07290109141954
• UDI-Public: (01)07290109141954
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/17/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown