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

Model Number	GA-2003477
Medical Device Problem Codes	Defective Device (2588); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blast shield lens was burnt during the procedure and the blast shield lens and probe were replaced but the output seems weak.The procedure was completed with a non-bsc product without patient complications.
Additional Manufacturer Narrative
The console was not returned for analysis; however, a field service engineer (fse), conducted an onsite visual inspection of the console.While performing the visual inspection the fse found the probe and two blast shields to be defective.After replacing the two blast shield lens assemblies, performing a laser optical axis adjustment, and output check the reported complaint of low power output was resolved.Based on the field service performed, it is most likely that the damaged probe and debris shields could have affected the device performance thus confirming the reported finding.H3 other text : device remains at health care facility.
Event or Problem Description
It was reported that the blast shield lens was burnt during the procedure and the blast shield lens and probe were replaced but the output seems weak.The procedure was completed with a non-bsc product without patient complications.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidman 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: 17909371
• Report Number: 2124215-2023-55968
• Device Sequence Number: 6653284
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: 07290109145440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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-2003477
• Device Catalogue Number: GA-2003477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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