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

Model Number	GA-0006800
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during daily inspection of the device, the energy of the console was low.There was no patient or procedure involved.
Additional Manufacturer Narrative
This console was serviced at the customer's site.The reported event was confirmed.The field service engineer (fse) replaced the lens, which resolved the issue.It is likely that the damaged lens could have affected the device performance, leading to the reported event.Based on the available information, the most probable cause was determined to be cause traced to component failure.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the reported event.
Event or Problem Description
It was reported that the energy was low.There was no patient involvement.

• Brand Name: PULSE
• 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 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17805666
• Report Number: 2124215-2023-51580
• Device Sequence Number: 7146965
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown