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

Model Number	GA-0006800
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that laser shut down in the middle of case.Laser ran fine an hour ahead.Then, error 11 (main controller communication (recovery failed)) was displayed.Machine was manually shut off and when machine back on had the same issues.Procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose was under general anesthesia.
Additional Manufacturer Narrative
D3 manufacturing email: (b)(6).This console was evaluated by a field service engineer (fse) at the customers site.During functional evaluation of the console, the system was started and error 11 was displayed immediately.The fse replaced the mmcu (main controller) board and burned the firmware software, restoring the console functionality.The console passed all tests and is ready for use.Also, the mmcu component was returned for analysis.During the analysis, the mmcu was identified to have a communication with the machine.The returned mmcu passed all tests.Even though the fse replaced the mmcu, analysis of the product was unable to replicate the allegation.Based on analysis results and information available, the reported allegations were not confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that laser shut down in the middle of case.Laser ran fine an hour ahead.Then, error 11 (main controller communication (recovery failed)) was displayed.Machine was manually shut off and when machine was turned on again it had the same issues.It was noted that the console displayed errors 11, 101, and 120 at separate times, and all 3 of which point to mmcu comm problems.Procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose was under general anesthesia.
Additional Manufacturer Narrative
Corrected g1 mfr site address 1, corrected g1 mfr site address 2.Manufacturing email: (b)(6).This console was evaluated by a field service engineer (fse) at the customers site.During functional evaluation of the console, the system was started and error 11 was displayed immediately.The fse replaced the mmcu (main controller) board and burned the firmware software, restoring the console functionality.The console passed all tests and is ready for use.Also, the mmcu component was returned for analysis.During the analysis, the mmcu was identified to have a communication with the machine.The returned mmcu passed all tests.Even though the fse replaced the mmcu, analysis of the product was unable to replicate the allegation.Based on analysis results and information available, the reported allegations were not confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that laser shut down in the middle of case.Laser ran fine an hour ahead.Then, error 11 (main controller communication (recovery failed)) was displayed.Machine was manually shut off and when machine was turned on again it had the same issues.It was noted that the console displayed errors 11, 101, and 120 at separate times, and all 3 of which point to mmcu comm problems.Procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose was under general anesthesia.

• 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; yokneam industrial park; 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: 16479498
• Report Number: 2124215-2023-08675
• Device Sequence Number: 16931513
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2023

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-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000118
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 09/26/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 09/01/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown