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

Model Number	RG0638-803-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console is having low power.There was no patient involvement.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported low power could not be confirmed.The fse powered the instrument on and found the internal calibrations to be as required by the manufacture's specification.The fse recalibrated and verified the pyros are within the manufacturer's specification and checked that the coolant was at max level.All optics passed all pretest requirements.The instruments power was found to meet the clients specific power requirements.Based on fse evaluation, investigation was unable to identify any damage related to the reported allegation.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the console is having low power.There was no patient involvement.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 23659192
• Report Number: 2124215-2025-85947
• Device Sequence Number: 21345951
• Product Code: GEX
• UDI-Device Identifier: 07290109145853
• UDI-Public: (01)07290109145853(11)070806
• 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): 02/02/2026

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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/02/2026
• 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