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

Model Number	GA-2000000
Medical Device Problem Codes	Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the biomedical engineer that the console system's aiming beam is not correctly aligned, and the system is not outputting the correct amount of energy.There was no patient involved with the event.
Event or Problem Description
It was reported by the biomedical engineer that the console system's aiming beam is not correctly aligned, and the system is not outputting the correct amount of energy.There was no patient involved with the event.
Additional Manufacturer Narrative
Correction provided in h11 to describe work done on console at customer's facility.It was reported that the console was serviced by a field service engineer (fse) at the customer's facility.The fse inspected the device and found that the ram had two optics and bearings that needed to be repaired.The arm was replaced, and then the console was within specifications and ready for use.The articulated arm was later received for analysis at our quality assurance laboratory.The device underwent thorough analysis.Visual examination of the arm found it was in good physical condition.The arm swivels and bents without any issues.The lens look good and clear.

• Brand Name: ULTRAPULSE DUO
• 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: 20608459
• Report Number: 2124215-2024-69215
• Device Sequence Number: 7411237
• Product Code: GEX
• UDI-Device Identifier: 07290109140322
• UDI-Public: 07290109140322
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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
• Device Lot Number: 0000000053
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown