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

Model Number	0638-800-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was administered general anesthesia in preparation for a holmium laser enucleation of the prostate procedure.During preparation for the procedure, it was found that the touch screen on the console was not working properly.Pushing the buttons on the screen was not doing anything.The console was restarted but the issue did not resolve.The console was then shut down, unplugged, plugged back in, and then started again.The console passed self-test, but the touch screen still was not working.It was noted that no error codes were received.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that the patient was administered general anesthesia in preparation for a holmium laser enucleation of the prostate procedure.During preparation for the procedure, it was found that the touch screen on the console was not working properly.Pushing the buttons on the screen was not doing anything.The console was restarted but the issue did not resolve.The console was then shut down, unplugged, plugged back in, and then started again.The console passed self-test, but the touch screen still was not working.It was noted that no error codes were received.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
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 able to confirm that the console starts without an errors and the touch screen is not working.The display panel was replaced.The console then powered up without any errors and the touchscreen was working.It was verified the safety circuits were all working properly.The console was ready for use.The touch display screen was returned and upon receipt at our quality assurance laboratory it was thoroughly analyzed.Visual inspection identified the device was in overall good physical condition, and the electrical connector was in good shape.Based on the information available, it is probable that the damaged screen led to the event reported by the customer.Replacing the touch screen resolved the reported event.
Event or Problem Description
It was reported that the patient was administered general anesthesia in preparation for a holmium laser enucleation of the prostate procedure.During preparation for the procedure, it was found that the touch screen on the console was not working properly.Pushing the buttons on the screen was not doing anything.The console was restarted but the issue did not resolve.The console was then shut down, unplugged, plugged back in, and then started again.The console passed self-test, but the touch screen still was not working.It was noted that no error codes were received.The procedure was then cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17837884
• Report Number: 2124215-2023-53375
• Device Sequence Number: 15396118
• Product Code: GEX
• UDI-Device Identifier: 07290109146164
• UDI-Public: 07290109146164
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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: 0000000341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 01/23/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/01/2023; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown