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

Model Number	0638-803-00
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	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser made a noise and then the screen displayed red.Error log showed error 504.The physician was unable to use the laser for the procedure.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that the laser made a noise and then the screen displayed red.Error log showed error 504.The physician was unable to use the laser for the procedure.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Upon receipt of the case report and work order for the console, a thorough review was performed.The allegations were confirmed, as the controller, bricks, and blast shield were damaged.These components could have caused or contributed to the reported event.There were no manufacturing or design issues found; therefore, the cause was traced to component failure.

• 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; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15686485
• Report Number: 2124215-2022-42870
• Device Sequence Number: 20672509
• Product Code: GEX
• UDI-Device Identifier: 07290109145853
• UDI-Public: 07290109145853
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 0638-803-00
• Device Catalogue Number: 0638-803-00
• Device Lot Number: 003-58405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown