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

Model Number	0638-804-00
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, it was found that the console alerted error code 201 - shutter test failed when turned on.The procedure was not completed due to this event.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The device or components were not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the reported error 201 displayed by the console was caused due to the mechanical dual shutters damage.The fse proceeded to replaced it and the issue was resolved; the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely that the error message resulted from an electrical issue, leading to the reported event.Therefore, the reported allegation was confirmed.A risk review was completed and confirmed that the event of device - device displays error message is defined in the risk documentation.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure, it was found that the console alerted error code 201 - shutter test failed when turned on.The procedure was not completed due to this event.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Correction to field b5: describe event or problem correction to field f10: impact codes correction to field h6: impact codes correction to field h11: additional mfr narrative the device or components were not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the reported error 201 displayed by the console was caused due to the mechanical dual shutters damage.The fse proceeded to replaced it and the issue was resolved; the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.No further issues were identified during service, and the console was confirmed to be fully functional after repairs.It is likely that the error message resulted from an electrical issue, leading to the reported event.Therefore, the reported allegation was confirmed.A risk review was completed and confirmed that the event of device - device displays error message is defined in the risk documentation.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.After that, additional information was received by good faith effort indicating that this procedure was not aborted, and the patient was not under sedation when the event occurred.The issue was resolved post procedure by replacing the shutter.Based on this new information received, the manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the reported aborted/cancelled procedure with a patient under anesthesia or sedation.
Event or Problem Description
It was reported that during a procedure, it was found that the console alerted error code 201 - shutter test failed when turned on.The issue was resolved post procedure by replacing the shutter.There was no patient complication.

• 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: 24290501
• Report Number: 2124215-2026-07061
• Device Sequence Number: 10324436
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)130625
• 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,Followup
• Report Date (Section B): 05/13/2026

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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 04/14/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/13/2026; 05/13/2026
• Date Device Manufactured: 06/25/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown