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

Model Number	0638-807-01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser output was weak.The console did not display a courtesy message nor error code.The procedure was completed with the original device.There were no patient complications.
Additional Manufacturer Narrative
The console was field service at the user's facility, field services identified that the debris shield of the console was burned.Therefore, the reported event was confirmed.After replacing the debris shield the console was within specification and functioning as intended.In addition, it was identified that the laser oscillator tube was slightly burn.A replacement was recommended.Operation check was performed, the cooling water was refilled, no further issues were identified.

• 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: 21437100
• Report Number: 2124215-2025-09651
• Device Sequence Number: 4606280
• Product Code: GEX
• UDI-Device Identifier: 07290109146225
• UDI-Public: 07290109146225
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: Other
• Device Model Number: 0638-807-01
• Device Catalogue Number: 0638-807-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/21/2025
• Date Device Manufactured: 05/21/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown