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

Model Number	GA-1008942
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during firing, the device had a loud popping sound and burning smell.There was no report of procedure or patient involvement.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the customer's facility by a field service engineer (fse).The fse confirmed the reported allegation of device noise/audible and smoking.According to case comments, the debris shield was defective and replaced.It was tested with a new fiber, and there seem to be no further issues.The malfunction found could have affected the device performance, leading to the event experienced by the customer.A review for device history review (dhr)/service history was completed and states that the device was installed on (b)(6) 2017, and this event occurred eight years after the system installation.After this period, component wear, failure, or damage is possible based on product use.A review of the device instructions for use (ifu), using p50h p100h hazard analysis, was performed and includes specific warnings related to "loud popping sound and burning smell," such as: popping or tapping coming sound from the fiber port: this is probably due to a malfunction of the optical fiber connector, and optical fiber burn back may occur during prolonged procedures, especially when using higher power.The investigation conclusion code assigned is cause traced to component failure, which indicates expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during firing, the device had a loud popping sound and burning smell.There was no report of procedure or patient involvement.

• 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: 22636761
• Report Number: 2124215-2025-50019
• Device Sequence Number: 13074428
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)160927(10)43
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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-1008942
• Device Catalogue Number: GA-1008942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 09/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown