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

Model Number	0638-809-01
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when this console was started, error code 703 appeared, and it could no longer be used.The procedure was cancelled due to this error.There were no patient complications.This event is being reported due to the procedure being aborted post the administration of sedation/sedation administration is unknown.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).During service, error 703 occurred, thus confirming the reported allegation.The di filter, particle filter, air filter, blast shield and cooling water were replaced, which resolved the issue.The console was confirmed to be performing as expected after those components were replaced.According to the analysis results and information available, the error code displayed is related to a deterioration of the cooling-related filter.
Event or Problem Description
It was reported that, when this console was started, error code 703 appeared, and it could no longer be used.The procedure was cancelled due to this error.There were no patient complications.This event is being reported due to the procedure being aborted post the administration of sedation/sedation administration is unknown.

• 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: 20242372
• Report Number: 2124215-2024-56595
• Device Sequence Number: 17970112
• Product Code: GEX
• UDI-Device Identifier: 07290109140568
• UDI-Public: 07290109140568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 0638-809-01
• Device Catalogue Number: 0638-809-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 06/20/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown