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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, power reduction was found.The procedure was completed with this device.There were no patient complications.
Additional Manufacturer Narrative
The console 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, there was found that the device was functioning normally with proper output power.Therefore, the reported allegations could not be confirmed.According to the device history record review, it was installed on 8/31/2015 and this event occurred 10 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on all the available information objective evidence from the product analysis being unable to confirm the reported complaint, this investigation is being assigned a conclusion code of no problem detected.Based on this analysis, the manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the power reduction initially reported.
Event or Problem Description
It was reported that during the procedure, power reduction was found.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; hakidma st 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23404785
• Report Number: 2124215-2025-74515
• Device Sequence Number: 4902238
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)141022(10)1765
• 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
• Report Date (Section B): 12/19/2025

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
• Device Lot Number: 0000001765
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 10/22/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown