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

Model Number	GA-0006600
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the console had a burnt smell.The procedure was completed without replacing the device.There was no patient complication.
Additional Manufacturer Narrative
The console was 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 reported event was not confirmed due to the issue was related to the fiber and not the console.The labeling review was performed and there was no indication that the device was not used in accordance with the ifu.Based on the work order, the issue was related to the fiber and not the console.Since the investigation was unable to identify any damage or malfunction related to the reported allegation, the investigation conclusion code selected for the complaint is no problem detected.
Event or Problem Description
It was reported that during a procedure the console had a burnt smell.The procedure was completed without replacing the device.There was no patient complication.

• 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: 22065279
• Report Number: 2124215-2025-31674
• Device Sequence Number: 8328602
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: (01)07290109140551(10)110126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: GA-0006600
• Device Catalogue Number: GA-0006600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 01/26/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown