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

Model Number	RG0638-803-00
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that during capital equipment maintenance the console optics had an energy delivery output/failure due to the laser console was providing low wattage.This laser is used to test bsc products.No for human use.There was no patient involved.This event is being reported for low power.
Additional Manufacturer Narrative
The device or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the oc mirror, high reflector mirror and brick were defective due to the ch2 laser brick and ch2 hr were pitted.The fse replaced them and the power was returned to the correct parameters after the parts had been installed; therefore, the console was confirmed to be fully functional.It is likely that this malfunction found could have affected the device performance leading to the event experienced by the customer.A risk review was completed and confirmed that the event of low power is defined in the risk documentation.Based on review of all information available and analysis results, since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that during capital equipment maintenance the console optics had an energy delivery output/failure due to the laser console was providing low wattage.This laser is used to test bsc products.No for human use.There was no patient involved.This event is being reported for low power.

• 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: 24210401
• Report Number: 2124215-2026-05243
• Device Sequence Number: 5484280
• Product Code: GEX
• UDI-Device Identifier: 07290109145853
• UDI-Public: (01)07290109145853
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/16/2026

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: RG0638-803-00
• Device Catalogue Number: RG0638-803-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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