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

Model Number	GA-0006801
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console prompted errors 273, 254, and 162, and the procedure could not be completed.It was unknown if the patient was under sedation.There were no patient complications.Boston scientific has been unable to obtain additional information despite good-faith efforts.
Additional Manufacturer Narrative
Upon receipt of the brick and the pmcu board at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the device found the brick was in overall good physical condition, the ends were intact with all screws in place.It was also noted that there was no leakage along the end cap seams, the body was clean and light shines through the rod.The hv pmcu board was visually inspected and one of the components were found broken.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on analysis results, a conclusion code of cause traced to component failure which indicates that expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the console prompted errors 273, 254, and 162, and the procedure could not be completed.It was unknown if the patient was under sedation.There were no patient complications.Boston scientific has been unable to obtain additional information despite good-faith efforts.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; israel; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20117749
• Report Number: 2124215-2024-51785
• Device Sequence Number: 7349780
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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-0006801
• Device Catalogue Number: GA-0006801
• Device Lot Number: 0000000298
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 10/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown