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

Model Number	0638-803-00
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	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console presented low wattage.There was no patient involved, as the console is a testing device and not used with patients.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.The console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and performed a cleaning and alignment of all laser channels and re-calibrated pyros.After that, the problem was resolved, thus confirming the reported event.The malfunction found could have affected the device performance leading to the event experienced by the customer.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the console presented low wattage.There was no patient involved, as the console is a testing device and not used with patients.

• 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 ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23881945
• Report Number: 2124215-2025-92749
• Device Sequence Number: 13163200
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)081231(10)25
• 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: Non-Healthcare 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: 0638-803-00
• Device Catalogue Number: 0638-803-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 12/31/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown