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

Model Number	GA-0006902
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the console device displayed error 58 and error 270 and stopped working.The procedure was canceled.There was no reported permanent impairment or injury to the patient.This event is being reported for a cancelled procedure with the patient under sedation or sedation status unknown.
Event or Problem Description
It was reported that, during a procedure, the console device displayed error 58 and error 270 and stopped working.The procedure was canceled.It was later reported that it turned out to be a user error, the key was not turned on properly and the event had resolved.No patient complications were reported.This event is being reported for a cancelled procedure with the patient under sedation or sedation status unknown.
Event or Problem Description
It was reported that, during a procedure, the console device displayed error 58 and error 270 and stopped working.The procedure was canceled.It was later reported that it turned out to be a user error, the key was not turned on properly and the event had resolved.No patient complications were reported.This event is being reported for a cancelled procedure with the patient under sedation or sedation status unknown.
Additional Manufacturer Narrative
Based on the available information, the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.However, troubleshooting was performed over the phone, and it was determined that the key was not turned on properly.The cause that contributed to the reported error messages and stopped working was due to the key not turned on properly.Once the key was turned to the on position the console was working as intended.The reported error messages and console shutting down cannot be confirmed.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma 6; yokneam ; IS
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16415052
• Report Number: 2124215-2023-07874
• Device Sequence Number: 3290076
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: 07290109145150
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/22/2023

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-0006902
• Device Catalogue Number: GA-0006902
• 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: 02/05/2023
• Supplement Date Received by Manufacturer: 03/02/2023; 05/12/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/22/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown