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

Model Number	GA-0006900
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the device started to rattle loudly and a scorched smell was detected.The physician was not able to laser any longer so the procedure was aborted.This event is being reported for an aborted procedure with the patient under general anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Upon review of the work order at our quality assurance laboratory, the console was thoroughly analyzed.During testing, the console shutdown multiple times and the power supply for up to 24v was identified as defective and was replaced.The dc/dc board was reported as damaged and replaced.The returned board was noted as in overall good condition; however, with the replacements made to the unit, the unit started working again.Based on the information available, the analysis confirmed that the product performance could have been caused by the component failure.Manufacturer email: (b)(4).
Event or Problem Description
It was reported that during a procedure the device started to rattle loudly and a scorched smell was detected.The physician was not able to laser any longer so the procedure was aborted.This event is being reported for an aborted procedure with the patient under general anesthesia or sedation status unknown.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16211083
• Report Number: 2124215-2023-01885
• Device Sequence Number: 17228583
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: 07290109145402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/04/2023

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
• Device Lot Number: 0000000059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown