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

Model Number	GA-0008800
Medical Device Problem Codes	Output below Specifications (3004); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the aiming beam is faded, and the aiming beam output is low.In addition, there is noise when turned on.The console is still functional, and no error message is given.No further information was provided.
Additional Manufacturer Narrative
This p120 console was serviced at the customers site.The reported clinical observations were confirmed.Replacing the fiber focus (lens assy) resolved the issue.The console passed full functional testing.It is most likely that the normal usage wear of the fiber focus caused or contributed to the reported allegation.
Event or Problem Description
It was reported that, the aiming beam is faded, and the aiming beam output is low.In addition, there is noise when turned on.The console is still functional, and no error message is given.No further information was provided.

• 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: 19666632
• Report Number: 2124215-2024-40952
• Device Sequence Number: 6904842
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: 07290109145419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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-0008800
• Device Catalogue Number: GA-0008800
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 09/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown