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

Model Number	GA-0006801
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the console shut down during a procedure and was unable to be turned back on.There is no patient and procedure outcome reported.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that, the console shut down during a procedure and was unable to be turned back on.There is no patient and procedure outcome reported.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• 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 ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20790604
• Report Number: 2124215-2024-73296
• Device Sequence Number: 6989704
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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-0006801
• Device Catalogue Number: GA-0006801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 05/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White