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	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the device did not deliver sufficient power.There was no patient complications reported.
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 allegation of the device low power.The laser was inspected and tested by verifying its power output, and the reported issue was successfully duplicated.A worn blast shield was found and replaced, and the power output was verified.The device passed the inspection, and the system was confirmed to be ready for clinical use.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 device was installed on 20 november 2012, and this event occurred over 12 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 during procedure, the device did not deliver sufficient power.There was no patient complications reported.

• 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: 23418198
• Report Number: 2124215-2025-77423
• Device Sequence Number: 18413200
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: (01)07290109146195(11)121018(10)565
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 10/18/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown