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

Model Number	GA-0006900
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the console was started, it engaged the electrical security system.The power cord was found to be good condition, but the r1 on the ac board components were burnt.There was no procedure done due to this problem.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis and no work order was assigned to this case; however, media was provided by the customer.The media shows the r1 of the ac board was damaged.The review completed on the device history review (dhr) for this console confirmed that it met specification prior to release.Based on the information available, it is likely that the damaged ac board contributed to the event experienced by the customer.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that when the console was started, it engaged the electrical security system.The power cord was found to be good condition, but the r1 on the ac board components were burnt.The patient was under sedation at the time and no procedure was performed due to this problem.There was no patient complication.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 st. 6; 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: 17647178
• Report Number: 2124215-2023-46726
• Device Sequence Number: 20354551
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: 07290109145402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown