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	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when checking the device, it was found that the power was low.There was no patient involved.
Additional Manufacturer Narrative
The console was not returned to the manufacturer for investigation; however, it was serviced at user facility by field service engineer (fse).During evaluation of the console at user facility, it was identified that the components high reflector mirror and brick were defective.The brick was replaced; the issue was resolved and the console worked within the specifications.As a result, the console was functioning as intended, therefore the reported allegation is confirmed.It is likely that the defective components could have affected the device performance leading to the event experienced by the customer.The replaced brick was received at manufacturer for investigation.Upon receipt of the brick at quality assurance laboratory, the component was thoroughly analyzed.Visual inspection identified the brick was in overall good physical condition.The ends were intact with all screws in place.There was leakage along the end cap seams.The body had traces of residual on the surface, and the light shines through the rod.The console was installed on (b)(6) 2008, and this event occurred 17 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and confirmed that the event of low power was defined in the risk documentation.Based on review of all information available and analysis results, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that when checking the device, it was found that the power was low.There was no patient involved.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23457838
• Report Number: 2124215-2025-78264
• Device Sequence Number: 8056831
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)080309(10)6-70367
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown