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

Model Number	0638-807-01
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure post-sedation, the console showed red screen and it displayed error code all laser malfunction.After that, by additional information was notified that the procedure was discontinued as the device was defective.This event occurred outside the patient body, therefore there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that, after the patient had been sedated for a procedure, the console displayed a red screen, indicating case saver mode.An error code "all laser malfunction" was also displayed.The procedure was cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was found that the internal mirror was burnt.Therefore, the reported allegation was confirmed leading to the reported event.After replacing the internal mirror and flow switch, the issue was resolved, and the unit was within specification and as a result the console was functioning as intended.Most likely the damaged internal mirror and flow switch could have affected the device performance leading to the event experienced by the customer.No further issues were identified during service, and the console was confirmed to be fully functional after replacing.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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18083440
• Report Number: 2124215-2023-62329
• Device Sequence Number: 6713818
• Product Code: GEX
• UDI-Device Identifier: 07290109146225
• UDI-Public: 07290109146225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 0638-807-01
• Device Catalogue Number: 0638-807-01
• Device Lot Number: 0000000440
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown