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

Model Number	0638-809-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the facility of the customer by a field service engineer (fse).The blast shield was replaced.A functional test was performed based on the checklist, confirming that there were no problems with the output.One blast shield is being kept as a spare and inspected the fibers owned by the hospital and had them dispose the defective fibers.The usage of inspection scope was performed.The ifu states that is no indication that the device was not used in accordance with the ifu.The fse replacement of the blast shield has resolved the issue, and the unit was within specification.Therefore, 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 the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during procedure, the device's blast shield was burnout.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.
Additional Manufacturer Narrative
Updated block g2: report source, upon receipt at our quality assurance laboratory, the console device was not returned; however, it was serviced at the facility of the customer by a field service engineer (fse).The blast shield was replaced.A functional test was performed based on the checklist, confirming that there were no problems with the output.One blast shield is being kept as a spare, and the fibers owned by the hospital were inspected, with the defective fibers being disposed of.The usage of the inspection scope was performed.The ifu states that there is no indication that the device was not used in accordance with the ifu.The fse replacement of the blast shield has resolved the issue, and the unit was within specification.Therefore, 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 the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during procedure, the device's blast shield was burnout.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 21589887
• Report Number: 2124215-2025-15458
• Device Sequence Number: 8925673
• Product Code: GEX
• UDI-Device Identifier: 07290109140568
• UDI-Public: (01)07290109140568(11)140211(21)186
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 02/25/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 02/11/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown