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

Model Number	0638-804-00
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, it was found that the console seemed to have a power reduction.The procedure was completed using same console.No information regarding the patient outcome was provided.
Additional Manufacturer Narrative
The console was not returned for analysis; therefore, a technical analysis could not be performed, and the reported device performance allegation could not be confirmed.The device was originally installed on (b)(6) 2013 and this event occurred more than 1 year after the system installation, beyond the product one-year warranty period.Given the extended time in use after distribution, the issue is considered more likely due to use-related wear or field conditions rather than a potential manufacturing or design issue at the time of release.Therefore, a device history record (dhr) review was not conducted.A risk review was completed and confirmed that the event of device - low power was defined in the risk documentation and is documented accordingly in the product record review (prr).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 an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that during the procedure, it was found that the console seemed to have a power reduction.The procedure was completed using same console.No information regarding the patient outcome was provided despite performing 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: 24645796
• Report Number: 2124215-2026-15253
• Device Sequence Number: 18693839
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)121113
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 0638-804-00
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 11/13/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown