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

Model Number	0638-804-00
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a procedure, while the patient was under general anesthesia, after powering on and warming up, the console suddenly shutdown due to power loss and could not be restarted.The procedure was postponed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that during preparation for a procedure, while the patient was under general anesthesia, after powering on and warming up, the console suddenly shutdown due to power loss and could not be restarted.The procedure was postponed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console was field services at the user's facility.It was attempted to start up the console, but it failed.The power cord was firmly reseated.Then the console was tested and it was confirmed that the console was now functioning normally.The reported event was confirmed as after reseating the power cord, the console was within specification and functioning as intended.Service history review was completed and indicates that the installation and functional verification of the console was performed 21feb2008, the console was last service on 03mar2026.The console remained fully functional, with no issues reported until the last service and/or event date.Based on service records, the issue is more likely due to use-related wear or field conditions rather than manufacturing or design at release.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of surgical procedure delayed (prolonged procedure) 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 all available information an investigation conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 24767745
• Report Number: 2124215-2026-18085
• Device Sequence Number: 10064088
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)071226
• 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): 05/21/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 12/26/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male