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

Model Number	0638-800-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician found that the energy of the machine was low.The procedure was completed with this device without patient complications.
Event or Problem Description
It was reported that during the procedure, the physician found that the energy of the machine was low.The procedure was completed with this device without patient complications.Further information received from the facility indicated that the physician was aware of the low energy as the console displayed the message on the console screen.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.However, the console was serviced onsite by a field service engineer (fse).The machine was tested and found that the energy of one laser cavity was low.The 1st, 3rd and 4th laser cavities were found not to be the original laser console cavities.According to the device instructions for use, the ifu states the following: the laser is intended for use only with lumenis-qualified delivery systems.The manufacturer has reviewed all information and determined this event no longer meets the reporting criteria for the device in question.
Event or Problem Description
It was reported that during the procedure, the physician found that the energy of the machine was low.The procedure was completed with this device without patient complications.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.However, the console was serviced onsite by a field service engineer (fse).The machine was tested and found that the energy of one laser cavity was low.The 1sr, 3rd and 4th laser cavities were found not to be the original laser console cavities.According to the device instructions for use, the ifu states the following: the laser is intended for use only with lumenis-qualified delivery systems.

• 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; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21127216
• Report Number: 2124215-2024-83086
• Device Sequence Number: 17848730
• Product Code: GEX
• UDI-Device Identifier: 07290109140582
• UDI-Public: 07290109140582
• 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,Followup
• Report Date (Section B): 02/07/2025

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: 0638-800-00
• Device Catalogue Number: 0638-800-00
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 01/12/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/06/2025; 02/07/2025
• Date Device Manufactured: 09/29/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown