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	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the device's power was insufficient.The procedure was completed using the original device.There were no patient complications reported.
Additional Manufacturer Narrative
The console device was not returned to the service center but was serviced on-site at the customers facility by a field service engineer (fse).The fse confirmed the reported issue of the device low power.The machine was reported to be delivering low energy.The system was inspected, and all optics and mirrors were found to be in good condition.Alignment and calibration were checked and found to be within the acceptable range.Calibration was performed again, and all parameters remained within range.The machine is working properly and is ready for surgical use.The system is fully operational.However, even though the allegation was confirmed, the most probable cause of the reported issue cannot be established due to lack of evidence.This device was installed on 04 march 2014, and this event occurred over 11 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of low power was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation, since the problems were traced to the device, but the investigation could not identify the actual root cause (e.G., design, manufacturing, component).
Event or Problem Description
It was reported that during procedure, the device's power was insufficient.The procedure was completed using the original device.There were 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: 24401767
• Report Number: 2124215-2026-09570
• Device Sequence Number: 18574534
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)131215(10)1674
• 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): 03/11/2026

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
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 12/15/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown