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

Model Number	0638-800-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, it was found that the energy level was low, with the maximum being 20w.The procedure was completed with this device.There were no patient complications.
Additional Manufacturer Narrative
The manufacturer has reviewed all available information and determined that this event no longer meets reporting criteria for the reported event of low energy output.The console had prompted case saver mode which indicates that the console was functioning as intended.The device was not returned; however, an onsite service evaluation was performed.During the service visit, the field service engineer did not observe red screen errors or automatic shutdowns.Inspection identified degraded beam quality on channel 4.Corrective actions included optical adjustment and verification of the 5vdc supply.Following these actions, the system successfully passed all functional and performance checks and was confirmed to operate within normal specifications.Based on the available service findings, the reported behavior was addressed during service intervention.No definitive evidence was identified to confirm a specific system operating mode or protection state at the time of the reported event.
Event or Problem Description
It was reported that during the procedure, it was found that the energy level was low, with the maximum being 20w.Additional information was received at a later time, reporting that this console was under case saver mode.The procedure was completed with this device.There were no patient complications.

• 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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24474517
• Report Number: 2124215-2026-10499
• Device Sequence Number: 9615480
• Product Code: GEX
• UDI-Device Identifier: 07290109140582
• UDI-Public: (01)07290109140582(11)160508(10)264
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 0638-800-00
• Device Catalogue Number: 0638-800-00
• Device Lot Number: 0000000264
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/22/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/21/2026
• Date Device Manufactured: 05/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown