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

Model Number	GA-0006902
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was making noises and the stop button was in a stuck position.There was no patient or procedure involved in this event.
Event or Problem Description
It was reported that the console was making noises and the stop button was in a stuck position.There was no patient or procedure involved in this event.
Additional Manufacturer Narrative
Upon receipt of the emergency switch at our quality assurance laboratory, this device was thoroughly analyzed, and its good condition was confirmed.The console was also serviced onsite by a field service engineer (fse).During functional evaluation of the console, it was identified via visual inspection that the emergency stop switch was in good condition, however after the fse replaced the component, the issue reported was resolved.No further issues were identified during service, and the console was confirmed to be fully functional after the replacement.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 18732256
• Report Number: 2124215-2024-09321
• Device Sequence Number: 12248190
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown