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

Model Number	0638-804-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the procedure, it was found that the energy was low.The procedure was completed using the original device.
Event or Problem Description
It was reported that after the procedure, it was found that the energy was low.The procedure was completed using the original device.There were no patient complications.
Additional Manufacturer Narrative
Correction to b5: describe event or problem.Correction to h6: impact codes.The console or components were not returned for analysis.However, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the high reflective mirror (hrm) was defective.The fse proceeded to replace the damaged component and after this, no further issues were identified during service, and the console was confirmed to be fully functional.It is likely that the defective high relay mirror was causing the low power, leading to the reported event.The instructions for use were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.Based on the information provided and analysis results, a conclusion code of cause traced to component failure 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; IS 55112
• MDR Report Key: 23853518
• Report Number: 2124215-2025-92101
• Device Sequence Number: 9599277
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)141112
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/19/2026

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: 0638-804-00
• Device Catalogue Number: 0638-804-00
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 11/12/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown