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

Model Number	0638-803-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before the procedure, the energy was weak.The patient was present at the time of the event.Information regarding the patient and procedure outcome was not provided.
Event or Problem Description
It was reported that, before the procedure, the energy was weak.The procedure was completed with the same console.No patient complications were reported.Further information received indicated that the console prompted a red screen, indicating that the console entered case saver mode.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the low power event.
Additional Manufacturer Narrative
The console was not returned; however, it was serviced on site.Service evaluation indicated that the system was experiencing low power during operation.Inspection identified abnormally high energy values at the lower end of channels 2 and 3.The flash lamps in both channels were replaced, after which the parameters returned to normal and the system tested successfully.No additional issues were identified.The malfunction identified could have affected device performance and contributed to the event experienced by the customer.The system was confirmed to be fully operational following service.A risk review was completed and confirmed that the event of 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 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24215471
• Report Number: 2124215-2026-05344
• Device Sequence Number: 20930763
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)090201(10)32
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 0638-803-00
• Device Catalogue Number: 0638-803-00
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 02/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown