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

Model Number	0638-803-01
Medical Device Problem Codes	Nonstandard Device (1420); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a fire smell coming from the laser while it was in storage.The last time the console had been used was 4 days prior to the smell being noticed.The console is not in use and has not been turned on due to the smell.There was no patient involvement.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, there was found the optic brick/cavity was defective, the field service engineer proceeded with the replacement of this component.Also, the fse confirmed the smoking smell was from the backside of the console and was caused by a rubber from a new footswitch the customer had begun using and was continuously leaved on the backside of the console.Therefore, the reported allegation of smoking was confirmed.Most likely the component damaged could have affected the device performance.No further issues were identified during service, and the console was confirmed to be fully functional after replacing.In addition, two bricks (laser source) and the flow switch were returned and analyzed, as the fse found during inspection that the flow switch was leaking and both bricks showed signs of oxidation.Both bricks were in good overall condition, with ends intact and screws secured.Leakage was noted along the end cap seams, residual material was present on the surfaces, and light was visible through the rods.The flow switch component was analyzed and was in good condition along with the electrical connections.No evidence was found to indicate a manufacturing or design related issue.A labeling review was performed, and it includes specific warnings/instructions related to smokey smell, such as: use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.Based on the information provided, the most probable cause of this issue is cause traced to component failure, since an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that there was a fire smell coming from the laser while it was in storage.The last time the console had been used was 4 days prior to the smell being noticed.The console is not in use and has not been turned on due to the smell.There was no patient involvement.

• 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: 23303787
• Report Number: 2124215-2025-73198
• Device Sequence Number: 13288708
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: (01)07290109146195(11)070806(10)1-27282
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 0638-803-01
• Device Catalogue Number: 0638-803-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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