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	01/20/2026
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 the console was presenting low wattage.There was no patient involved.
Event or Problem Description
It was reported that the console was presenting low wattage.There was no patient involved.
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.The device was not returned for analysis; therefore, a technical analysis could not be performed.However, the console was serviced onsite by a field service engineer (fse).The field service engineer performed a physical inspection of the console and confirmed the reported condition.The channel brick, channel 2 optical connector, and the lens cell assembly lens were replaced.The system is vendor-used and not utilized on patients; therefore, vendor-specific testing was performed, and the standard checklist was not applicable.After service activities, the system was confirmed to be fully operational.The 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 device low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause 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.; 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: 24335055
• Report Number: 2124215-2026-08298
• Device Sequence Number: 9773081
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/09/2026
• 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