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

Model Number	GA-0006802
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the footswitch is sticking when pressed, causing the machine to flash the orange light and says lasing but it was not actually lasing.The e-stop was pushed, restarted unit and the procedure was completed without using the footswitch.The patient was stable under general anesthesia.
Additional Manufacturer Narrative
Upon receipt of this console component at our quality assurance laboratory, this device was thoroughly analyzed.During functional evaluation, there was found that the footswitch was defective and required replacement.Therefore, the reported allegation was confirmed leading to the reported event.After replacing it, the functional test was performed, 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 footswitch is sticking when pressed, causing the machine to flash the orange light and says lasing but it was not actually lasing.The e-stop was pushed, restarted unit and the procedure was completed without using the footswitch.The patient was stable under general anesthesia.
Event or Problem Description
It was reported that during a procedure the footswitch is sticking when pressed, causing the machine to flash the orange light and says lasing but it was not actually lasing.The e-stop was pushed, restarted unit and the procedure was completed without using the footswitch.The patient was stable under general anesthesia.
Additional Manufacturer Narrative
Upon receipt of this console component at our quality assurance laboratory, this device was thoroughly analyzed.During functional evaluation, there was found that the footswitch was defective and required replacement.Therefore, the reported allegation was confirmed leading to the reported event.After replacing it, the functional test was performed, 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.The device history record (dhr) met all material, assembly and performance specifications.A risk review was completed and confirmed that the event of foot switch pedal - stuck in on position is defined in the risk documentation.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.

• 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: 21859411
• Report Number: 2124215-2025-24205
• Device Sequence Number: 20007546
• Product Code: GEX
• UDI-Device Identifier: 07290109147185
• UDI-Public: (01)07290109147185(11)211010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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: 03/28/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 03/17/2026
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/30/2025; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown