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

Model Number	0638-804-01
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	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console was delivering reduced power at level 30.There was no patient involved.
Event or Problem Description
It was reported that the console was delivering reduced power at level 30.There was no patient involved.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the console was delivering reduced power at level 30.There was no patient involved.
Additional Manufacturer Narrative
The console was field service at the user's facility.All the optics and bricks were inspected as well as alignment on all channels for mode.It was identified that the high reflector mirror (hr) on channel 1 had been replaced in the past.Also, the brick was making strange noise while firing on channel 1.Adjustments were made on the hr mirror on channel 1 and found no mode.The hr assembly and a brick were requested for channel 1.The malfunction found could have affected the device performance leading to the event experienced by the customer.Service history indicated that the device was installed on (b)(6) 2022 and this event occurred 3 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review of the versapulse powersuite hazard analysis was completed and confirmed that the event of low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on all available information, the reported event of low power was confirmed, therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.

• 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 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23028191
• Report Number: 2124215-2025-62692
• Device Sequence Number: 13187013
• Product Code: GEX
• UDI-Device Identifier: 07290109146218
• UDI-Public: (01)07290109146218(11)220313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 0638-804-01
• Device Catalogue Number: 0638-804-01
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 03/04/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/19/2025; 04/01/2026
• Date Device Manufactured: 03/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown