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

Model Number	0638-804-00
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, it was found that the debris shield was damaged.In addition, the output power was low.It was suspected that the damage to the focusing lens was caused by the user's activation after the debris shield was damaged.It was required to clean the port, check and calibrate the optical path, check, clean or replace the focus lens, and calibrate the power.The procedure was completed using the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field g2: report source.The console was field service at the user's facility.The focus lens was checked, and it was clean and free of foreign matter.The optical path lens was normal; however, the optical path was adjusted.After performing the adjustment, the issue was resolved and the was within specification and functioning as intended.Therefore, the reported event was confirmed.
Event or Problem Description
It was reported that during procedure, it was found that the debris shield was damaged.In addition, the output power was low.It was suspected that the damage to the focusing lens was caused by the user's activation after the debris shield was damaged.It was required to clean the port, check and calibrate the optical path, check, clean or replace the focus lens, and calibrate the power.The procedure was completed using the original device.There were no patient complications reported.
Additional Manufacturer Narrative
The console was field service at the user's facility.The focus lens was checked, and it was clean and free of foreign matter.The optical path lens was inspected; then, it was adjusted.The console was then tested at full power 60 watts for 30 minutes and the energy was measure.After performing the adjustment on the optical path, the issue was resolved, and the console was within specification and functioning as intended.Therefore, the reported event was confirmed.
Event or Problem Description
It was reported that during procedure, it was found that the debris shield was damaged.In addition, the output power was low.It was suspected that the damage to the focusing lens was caused by the user's activation after the debris shield was damaged.It was required to clean the port, check and calibrate the optical path, check, clean or replace the focus lens, and calibrate the power.The procedure was completed using the original device.There were no patient complications reported.

• 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
• MDR Report Key: 22166637
• Report Number: 2124215-2025-37416
• Device Sequence Number: 18100262
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)140915
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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: 0638-804-00
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 07/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/09/2025; 08/11/2025
• Date Device Manufactured: 09/15/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown