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

Model Number	GA-2006378
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been sedated using general anesthesia in preparation for the procedure which was going to occur in the kidney.During the procedure, the console stopped working.The screen on the console turned light blue without any writing on it.Then, a message appeared on the screen.The console was restarted in accordance with the instructions on the screen.After a short period of use, the same device issue occurred.The physician then decided to turn the console off and not use it anymore.As a result, the surgeon was unable to use as much laser as she would have desired for the patient.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that the patient had been sedated using general anesthesia in preparation for the procedure which was going to occur in the kidney.During the procedure, the console stopped working.The screen on the console turned light blue without any writing on it.Then, a message appeared on the screen.The console was restarted in accordance with the instructions on the screen.After a short period of use, the same device issue occurred.The physician then decided to turn the console off and not use it anymore.As a result, the surgeon was unable to use as much laser as she would have desired for the patient.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis.However, the console was serviced by a field service engineer (fse) at the customer's facility.During investigation, the fse found a blue screen with the windows error message appeared twice during use.The lpu (computer) was replaced.The console was then tested and passed self-test.The console passed all checks, and no further errors were received.

• 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: 19050088
• Report Number: 2124215-2024-20779
• Device Sequence Number: 15264450
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: 07290109144665
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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-2006378
• Device Catalogue Number: GA-2006378
• Device Lot Number: 0000000014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown