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

Model Number	0638-807-01
Medical Device Problem Codes	Nonstandard Device (1420); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the debris shield is burnt and smoke was rising.The procedure was completed with this device.There were no patient complications.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer's site.During functional evaluation of the console, the reported allegation was confirmed.The fse found that the debris shield was burnt out, which may have led to the device performance issue.A risk review was completed and confirmed that the event of device - smoking was defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that the debris shield is burnt and smoke was rising.The procedure was completed with this device.There were no patient complications.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 24385436
• Report Number: 2124215-2026-09244
• Device Sequence Number: 10504847
• Product Code: GEX
• UDI-Device Identifier: 07290109146225
• UDI-Public: (01)07290109146225(11)100418(10)47
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 0638-807-01
• Device Catalogue Number: 0638-807-01
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown