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

Model Number	0638-807-01
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console presented low output mode during its use.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Date of event the exact date of the event is unknown, estimated.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The system was installed on 3/23/2011.This event occurred 13 years after the system installation.After this period, component wear, failure or damage is possible based on product use.System service, repair and/or component replacement may be performed or required to maintain the overall system functionality.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the console presented low output mode during its use.There was no patient involved.

• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19372259
• Report Number: 2124215-2024-31095
• Device Sequence Number: 7528439
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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
• Device Lot Number: C2E4412979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 02/27/2026; 04/16/2026
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 03/20/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown