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

Model Number	0638-804-00
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the user feels that the energy output had decreased compared to before.The procedure was completed using the same device.There were no patient complications.
Event or Problem Description
It was reported that during the procedure, the user feels that the energy output had decreased compared to before.The procedure was completed using the same device.There were no patient complications.
Additional Manufacturer Narrative
The console was field service at the user's facility.The console was inspected, and it was found that the protective lens showed signs of hot spots and is recommended to replace it.The console's fiber port was cleaned.The coolant level was checked and coolant was added.The console passed functional testing.After the fiber port was cleaned, the issue was resolved, and the console was within specification and functioning as intended.Therefore, the reported event of low power was confirmed.

• 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: 23537112
• Report Number: 2124215-2025-82422
• Device Sequence Number: 13268590
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)080813
• 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
• Report Date (Section B): 01/06/2026

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
• Device Lot Number: 005-73307
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 08/13/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown