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

Model Number	GA-2006098
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	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after turning on the unit and attempting to fire the laser, an error message stating to restart the system was displayed.The procedure was not completed due to this event and there were no patient complications.This event is being reported for aborted/cancelled procedure with patient with or unknown sedation.
Additional Manufacturer Narrative
D3.Manufacturer email (b)(4).As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse ran the self-test and pulled the error log file.Error 18 (switching modules over temp.) was found several times.The foot switch cord was found to be damaged, and the blast shield was worn.The fse replaced the switching module, foot switch and blast shield.The coolant was topped off.Alignment was performed.The laser console passed full functional and electrical safety testing.The switching module was returned to our quality assurance laboratory.Upon receipt, visual analysis did not identify any anomaly.The part was returned in overall good physical condition without significant signs of wear.The module passed all functional testing.Based on the analysis results, the reported error message was confirmed as replacing the switching module, foot switch and blast shield resolved the issue.There were no reported allegations regarding the foot switch and the blast shield.These damaged parts were likely not related to the customer reported allegation of error message, as the fse found error 18 (switching modules over temp), which reports an issue with the switching module, when checking the error log file.Although product analysis of the switching module did not identify any anomaly, replacing the switching module resolved the issue.Consequently, the damaged switching module is most likely the reason that caused the reported error message.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that after turning on the unit and attempting to fire the laser, an error message stating to restart the system was displayed.The procedure was not completed due to this event and there were no patient complications.This event is being reported for aborted/cancelled procedure with patient with or unknown sedation.

• Brand Name: 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16164798
• Report Number: 2124215-2023-01215
• Device Sequence Number: 7563108
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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-2006098
• Device Catalogue Number: GA-2006098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown