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

Model Number	GA-0006802
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the laser is not working properly.The resident was lasering, took his foot off the pedal, and the laser stopped emitting energy, but continued indicating lasing across the screen.The screen was not responsive when it was tried to turn the laser off.The emergency red stop button was used, and it did not work to stop the laser.The device was ended up unplugging it from the wall to get it to turn off.The procedure was completed with another device.There was no patient complication.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.According to the information gathered, even though the visual inspection mentions that the lpu was in good condition, the field service engineer states that the lpu was defective and required replacement.Therefore, the reported allegation was confirmed.After the field service engineer performed the replacement of the lpu, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during a procedure the laser is not working properly.The resident was lasering, took his foot off the pedal, and the laser stopped emitting energy, but continued indicating lasing across the screen.The screen was not responsive when it was tried to turn the laser off.The emergency red stop button was used, and it did not work to stop the laser.The device was ended up unplugging it from the wall to get it to turn off.The procedure was completed with another device.There was no patient complication.

• Brand Name: MOSES 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: 22342873
• Report Number: 2124215-2025-41491
• Device Sequence Number: 20964042
• Product Code: GEX
• UDI-Device Identifier: 07290109147185
• UDI-Public: (01)07290109147185(11)221206
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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-0006802
• Device Catalogue Number: GA-0006802
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown