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	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post procedure, the physician found that the unit had low power.The procedure was completed using this device.There were no patient complications.
Event or Problem Description
It was reported that post procedure, the physician found that the unit had low power.The procedure was completed using this device.There was no patient complications.
Additional Manufacturer Narrative
The console was serviced by the field service engineer (fse) at the customer site.Upon turned on the console, a red screen appeared, after checking it was found that the servo lens was damaged.After replacing the new lens and recalibrating the far and near field optical paths, the device returned to normal and the laser was tested normally.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the information available, the investigation conclusion code selected for this complaint is cause traced to component failure.

• 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 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22846965
• Report Number: 2124215-2025-58120
• Device Sequence Number: 4488684
• Product Code: GEX
• UDI-Device Identifier: 07290109140582
• UDI-Public: (01)07290109140582(11)130917(10)135
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 09/17/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown