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

Model Number	0638-803-01
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was unable to achieve 100 watts of energy.It was noted that the device has an energy device delivery output failure.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console device was not returned to the service center but was serviced on-site at the customer's facility by a field service engineer (fse).The fse confirmed the reported issue of the device low power.The device was checked thoroughly.A burnt spot was observed on the 550 fiber, so it was recommended to use a new fiber.A burnt spot was also found on the high resonator (hr) mirror in the third cavity, which was replaced.Alignment was performed, and the laser was fired at various settings with no errors observed.The self-test passed successfully.All service parameters were checked and found to be within specification.The instrument is now working fine.After the fse replaced the hr mirror, the issue was resolved, and the unit was back within specification.As a result, the console is now functioning as intended.The malfunction found could have affected the device performance, leading to the event experienced by the customer.The device history record (dhr) and service history record (shr) indicate that this p120 was installed on 12 january 2015, and this event occurred over 10 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that expected or random component failures were identified, with no design or manufacturing issues found.
Event or Problem Description
It was reported that the device was unable to achieve 100 watts of energy.It was noted that the device has an energy device delivery output failure.There was 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: 23155925
• Report Number: 2124215-2025-66449
• Device Sequence Number: 10180344
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: (01)07290109146195(11)101104(10)328
• 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): 11/12/2025

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: 0638-803-01
• Device Catalogue Number: 0638-803-01
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 11/04/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown