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

Model Number	0638-803-01
Medical Device Problem Codes	Energy Output Problem (1431); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console indicated that there was a fault and was not working correctly after 2 minutes of the laser bladder neck resection procedure.The bladder neck tissue could not be resected properly.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that the console indicated that there was a fault and was not working correctly after 2 minutes of the laser bladder neck resection procedure.The bladder neck tissue could not be resected properly.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 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: 21989443
• Report Number: 2124215-2025-29299
• Device Sequence Number: 20911128
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: (01)07290109146195(11)190926(10)964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/06/2025

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: Health Professional
• Device Model Number: 0638-803-01
• Device Catalogue Number: 0638-803-01
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/07/2025
• Date Device Manufactured: 09/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown