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

Model Number	GA-2003476
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse was not able to reproduce the error that the customer reported.Therefore, the reported allegation could not be confirmed.Based on the investigation results, here is no damage or malfunction related to the reported allegation and complaint or problem cannot be confirmed, the most probable cause of no problem detected is selected for the complaint.Date of event was not provided, estimated date entered.
Event or Problem Description
It was reported that, prior to the procedure, this console issued error 87 which indicates an issue with two or more bricks.Irradiation was not possible, so the procedure was rescheduled for the following month.The patient had already been sedated.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse was not able to reproduce the error that the customer reported.Therefore, the reported allegation could not be confirmed.Based on the investigation results, here is no damage or malfunction related to the reported allegation and complaint or problem cannot be confirmed, the most probable cause of no problem detected is selected for the complaint.
Event or Problem Description
It was reported that, prior to the procedure, this console issued error 87 which indicates a switching module (swm) issue with two or more bricks.Irradiation was not possible, so the procedure was rescheduled for the following month.The patient had already been sedated.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16206363
• Report Number: 2124215-2023-01694
• Device Sequence Number: 5627644
• Product Code: GEX
• UDI-Device Identifier: 07290109145457
• UDI-Public: 07290109145457
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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-2003476
• Device Catalogue Number: GA-2003476
• Device Lot Number: 0000000071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown