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

Model Number	0638-800-01
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Output below Specifications (3004); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, there was an unexpectedly shut off, the laser console was rebooted.It was tried to go above 0.6 joule and it shuts off again.An energy high fault message appeared; and it happened a couple times.The procedure was completed with this device, used at a lower setting, which took longer to complete but they were able to safely complete.The patient was under general anesthesia in stable condition, there were no patient complications.
Event or Problem Description
It was reported that during the procedure, there was an unexpectedly shut off, the laser console was rebooted.It was tried to go above 0.6 joule and it shuts off again.An energy high fault message appeared; and it happened a couple times.The procedure was completed with this device, used at a lower setting, which took longer to complete but they were able to safely complete.The patient was under general anesthesia in stable condition, there were no patient complications.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the fse was able to replicate customer complaint.When firing the laser at 0.6 joules, the unit will fault with energy high.Internal and external components on unit were inspected, performed near and far alignment on all 4 channels.Also, energy calibration was performed and made adjustments to meet technical manual specifications.After adjustment the fault went away, and the unit could fire the laser greater than 0.6 joules.Power checks were performed, the unit meets checklist power checks specifications, and the unit is ready for use.It is likely that the energy calibration was defective requiring adjustment.Therefore, the reported allegation is confirmed.After the calibration adjustment was performed, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: VERSAPULSE POWERSUITE
• 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 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19118930
• Report Number: 2124215-2024-22519
• Device Sequence Number: 18094468
• Product Code: GEX
• UDI-Device Identifier: 07290109146164
• UDI-Public: 07290109146164
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 0638-800-01
• Device Catalogue Number: 0638-800-01
• Device Lot Number: 0000000430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown