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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, it was found that the energy was low.There was no patient 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: 50927646
• Report Number: 2124215-2026-51601
• Device Sequence Number: 9509324
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/26/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown