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

Model Number	GA-1008944
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 303 (energy to high) was received.The procedure was not completed as a result of the event.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
D3.Manufacturer email: (b)(4).
Additional Manufacturer Narrative
This console was serviced at the customer's facility by a field service engineer (fse).The fse was unable to replicate the error reported by the customer.The pyro board and cpu (central processing unit) board were replaced.The optics were inspected and it was found that the hr optics were pitted on channels 1 and 3.Both hr optics were replaced.The fse then adjusted the beam mode on channel 1, and adjusted near alignment on channel 1 and 2.He verified the alignment on the pyro board was correct, and completed the pyro and energy calibrations.It was verified that energy output at all levels was appropriate, and the system passed all tests.The console was ready for use.The pyro board, hr resonator mirrors, and cpu board were returned.Upon receipt at our quality assurance laboratory, the devices were thoroughly analyzed.Visual inspection of the pyro board and cpu board identified they were in good physical condition.Visual inspection of the first hr mirror found it had white ash burn marks.The second hr mirror was cleaned and was found to have no marks on it.Based on the information available, it is probable that the reported event occurred due to the pyro board, the cpu board, and the hr mirrors being damaged.After the fse replaced the pyro board, cpu board, and hr mirrors, the reported event was resolved and the console was within specifications.
Event or Problem Description
It was reported that error 303 (energy to high) was received.The procedure was not completed as a result of the event.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.

• Brand Name: PULSE
• 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: 17552289
• Report Number: 2124215-2023-43660
• Device Sequence Number: 6695018
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: 07290109145969
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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-1008944
• Device Catalogue Number: GA-1008944
• Device Lot Number: 0000000373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown