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

Model Number	GA-1008942
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unusual noise was heard coming from the laser machine.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient under unknown anesthesia or sedation unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The reported event of device making strange noise was confirmed.Blast shield was inspected and found to be damaged.The blast shield was replaced, inspected and self-test passed with no errors and no strange sounds.Alignment checked for channels 3 and 4 was carried out.System was fired at 100w for 5 minutes with service fiber and also, fired at 100w for 5 minutes with slimline 200 fiber with no problems.The device instructions for use (ifu) was performed and confirmed that the reported patient effects of cancelled/rescheduled - post sedation/sedation unknown and surgical procedure delayed are listed in the ifu as potential outcomes of this procedure.There is no indication that the device was not used in accordance with the ifu.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that an unusual noise was heard coming from the laser machine.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient under unknown anesthesia or sedation 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 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23176024
• Report Number: 2124215-2025-68099
• Device Sequence Number: 21235678
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: (01)07290109140520(11)180314(10)128
• 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): 11/25/2025

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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 03/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown