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

Model Number	0638-803-00
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power of this device was insufficient.Also, displayed an error 'energy low - pulse energy is over 50% lower than requested.' there were no patient or procedure involved.
Additional Manufacturer Narrative
Upon further review of the available information to the manufacturer, it was determined that this event did not meet the reporting criteria for the device in question.The device was working as intended as it informed the user of the low power conditions of the device.There was no patient adverse event or device malfunction that required medical or surgical intervention to prevent patient harm.Additionally, there is no information to reasonably suggest that the reported malfunction, or their recurrence, could cause or contribute to death, serious injury, or serious deterioration in the health of a patient, user, or other person.The console was not returned for analysis; however, this console was serviced at the facility of the customer by a field service engineer (fse).The reported issue was unable to be replicated; however, work was performed on an old brick, which is a component of the console that's directly linked to the reported issue of low power.The component was replaced, and the console was working as intended.Based on the information available, the reported event is confirmed.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.Additionally, the event of low power was defined in the device's risk documentation and determined to be an acceptable risk benefit for the product.
Event or Problem Description
It was reported that the power of this device was insufficient.Also, displayed an error 'energy low - pulse energy is over 50% lower than requested.' there were no patient or procedure 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24151032
• Report Number: 2124215-2026-04133
• Device Sequence Number: 18391900
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)081225(10)22
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 0000000022
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 12/25/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown