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

Model Number	GA-2000000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The reported weak aiming beam was confirmed.The fse performed all optics bench, silo and arm optical alignment procedures, and found that the aiming beam out of the arm was still misaligned.The fse also cleaned and performed alignment of all mirrors and found they were uncompromised.Additionally, it was found that the arm was having issues and needed replacement, which 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 the beam out of the arm is misaligned and weak.The procedure was completed with another device.There were no patient complications.
Event or Problem Description
It was reported that the beam out of the arm is misaligned and weak.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The reported weak aiming beam was confirmed.The fse performed all optics bench, silo and arm optical alignment procedures, and found that the aiming beam out of the arm was still misaligned.The fse also cleaned and performed alignment of all mirrors and found they were uncompromised.Additionally, it was found that the arm was having issues and needed replacement, which 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 the beam out of the arm is misaligned and weak.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer's site.The reported weak aiming beam was confirmed.The fse performed all optics bench, silo and arm optical alignment procedures, and found that the aiming beam out of the arm was still misaligned.The fse also cleaned and performed alignment of all mirrors and found they were uncompromised.Additionally, it was found that the arm was having issues and needed replacement, which could have affected the device performance leading to the event experienced by the customer.The articulated arm was returned.Visual analysis identified that the arm was in good physical condition, it swivels and bends with no issues and also locks in place when lock button is pressed and releases when it's unlocked.The lens looks good and clear.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.

• Brand Name: ULTRAPULSE DUO
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21641995
• Report Number: 2124215-2025-15496
• Device Sequence Number: 7625082
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: (01)07290109140322(11)231224(10)1078(21)1078
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K203544
• 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,Followup
• Report Date (Section B): 06/25/2025

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-2000000
• Device Catalogue Number: GA-2000000
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 05/08/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/04/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown