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	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the laser was not doing the shape, the physician indicated that the movement of the handle did not translate to same movement of the laser pointer.The procedure was completed with another type of laser.There were no patient complications.
Additional Manufacturer Narrative
A work order was performed for this case, field service engineer inspected and tested the laser's micromanipulator and scanner.It was found that the micromanipulator was out of alignment and the micromanipulator joystick bent.The malfunction found could have affected the device performance leading to the event experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during a procedure, the laser was not doing the shape, the physician indicated that the movement of the handle did not translate to same movement of the laser pointer.The procedure was completed with another type of laser.There were no patient complications.

• 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21389583
• Report Number: 2124215-2025-08375
• Device Sequence Number: 8471245
• Product Code: GEX
• UDI-Device Identifier: 07290109141916
• UDI-Public: 07290109141916
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: AA3042000
• Device Catalogue Number: AA3042000
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown