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

Model Number	0638-803-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the device experienced a power reduction.The case was completed using the original device.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and was able to confirm the reported observation.The device was displaying a red screen at the time of evaluation.The fse replaced the second reflector on the first channel, after which the device operated as expected.Following this service activity, the system was verified to be fully functional.A risk review was completed and confirmed that the event of low power was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned a conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that during the procedure, the device experienced a power reduction.The case was completed using the original device.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 24344795
• Report Number: 2124215-2026-08490
• Device Sequence Number: 10041012
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: (01)07290109146171(11)140501(10)1725
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 0638-803-00
• Device Catalogue Number: 0638-803-00
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 05/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown