MAUDE Adverse Event Report: LUMENIS LTD Pulse; Powered Laser Surgical Instrument

Model Number	GA-2003322
Medical Device Problem Codes	Computer Software Problem (1112); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation post-sedation, the console displayed error codes 49 pyro main not equal to pyro safe and error code 54 sw autocal fault: n=1 / not done: n=2.The procedure was discontinued due to device defect.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that during preparation post-sedation, the console displayed error codes 49 pyro main not equal to pyro safe and error code 54 sw autocal fault: n=1 / not done: n=2.The procedure was discontinued due to device defect.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 console was not returned for analysis; however, it was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that there was a failure of cpu board.Therefore, the reported event was confirmed; the board was damaged, and it was replaced.It is likely this malfunction 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.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.

• Brand Name: Pulse
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): Boston Scientific Corporation; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23880421
• Report Number: 2124215-2025-92725
• Device Sequence Number: 14620543
• Product Code: GEX
• UDI-Device Identifier: 07290109145983
• UDI-Public: (01)07290109145983(11)241125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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-2003322
• Device Catalogue Number: GA-2003322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 08/21/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/09/2026; 09/14/2026
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown