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

Model Number	GA-0006600
Medical Device Problem Codes	Output below Specifications (3004); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was field service at the user's facility.The field service engineer confirmed the reported event of the console displaying a red screen and even when the power is turned on, the console shuts off immediately.Then, setup work was performed for the replacement unit.The console was installed on 2/12/2013 and this event occurred over 13 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review of the versapulse powersuite hazard analysis was completed and confirmed that the event of surgical procedure delayed 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, even though the allegation was confirmed, the most probable cause of the reported issue cannot be established due to lack of evidence.Therefore, an investigation conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, while the patient was under general anesthesia, the console would displayed red screen and even when the power is turned on, the console shuts off immediately.Also, the console would not turn on.The procedure was not completed 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.

• 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: 24694782
• Report Number: 2124215-2026-16501
• Device Sequence Number: 21442430
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: (01)07290109140551(11)120919
• 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,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: GA-0006600
• Device Catalogue Number: GA-0006600
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 09/19/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown