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

Model Number	GA-0006801
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was serviced at the customer site.During functional evaluation, the field service engineer (fse) replaced the footswitch, restoring the console's functionality.The malfunction found could have affected the device performance leading to the event experienced by the customer.Upon receipt of the foot pedal at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the foot pedal was in good condition.Functional testing did not find any abnormalities with the foot pedal.Based on available information, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the foot pedal is damaged.There were no patient complications.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; yokneam industrial park; hakidma st 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: 19472163
• Report Number: 2124215-2024-33728
• Device Sequence Number: 3394091
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown