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	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device had energy low.There were no report of patient or procedure involved.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 01/01/2026, based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that this device had energy low.There were no report of patient or procedure involved.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 01/01/2026, based on the date the manufacturer became aware of the event.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 did not find any damage or malfunction related to the low power allegation.The complaint was not confirmed.Device was installed on (b)(6) 2022 and this event occurred over 3 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 is defined in the risk documentation.Based on the information available, a conclusion code of device problem excluded 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24293318
• Report Number: 2124215-2026-07177
• Device Sequence Number: 21186006
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)220627(10)2199
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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
• Device Lot Number: 0000002199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 05/28/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/16/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown