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

Model Number	GA-0006800
Medical Device Problem Codes	Defective Device (2588); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was displaying low power.No error messages were displayed.What is occurring is that when the console is being used, the debris shield and fiber are not transmitting the holmium power through both parts.The result is low power transmission through the fiber.The tech replaced the debris shield and the fiber to resolve the event.There was no patient involved with the event.
Additional Manufacturer Narrative
The device was not returned for analysis.However, the console was serviced at the customer's facility.The field service engineer confirmed the debris shield was damaged.The debris shield was replaced.The console system was checked and found to be ready for use.
Event or Problem Description
It was reported that the console was displaying low power.No error messages were displayed.What is occurring is that when the console is being used, the debris shield and fiber are not transmitting the holmium power through both parts.The result is low power transmission through the fiber.The debris shield was damaged.The tech replaced the debris shield and the fiber to resolve the event.There was no patient involved with the event.
Event or Problem Description
It was reported that the console was displaying low power.No error messages were displayed.What is occurring is that when the console is being used, the debris shield and fiber are not transmitting the holmium power through both parts.The result is low power transmission through the fiber.The debris shield was damaged.The tech replaced the debris shield and the fiber to resolve the event.There was no patient involved with the event.
Additional Manufacturer Narrative
The console was serviced at the customer's facility.The field service engineer confirmed the debris shield was damaged.The debris shield was replaced.The console system was checked and found to be ready for use.The debris shield was later returned and underwent thorough analysis upon receipt at our quality assurance laboratory.Visual examination of the debris shield found white ash burnt marks on it.

• 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: 20678805
• Report Number: 2124215-2024-71433
• Device Sequence Number: 7230220
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• 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,Followup
• Report Date (Section B): 03/12/2025

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-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000154
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 02/16/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/13/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown