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

Model Number	GA-2003322
Medical Device Problem Codes	Problem with Software Installation (3013); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure and after sedation of the patient, the console issued error code 4 (footswitch fault).The procedure was cancelled due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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: 24714965
• Report Number: 2124215-2026-16936
• Device Sequence Number: 12259433
• Product Code: GEX
• UDI-Device Identifier: 07290109145983
• UDI-Public: (01)07290109145983(11)231127
• 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: Nurse
• 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
• Device Lot Number: 0000003050
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 08/21/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/29/2026; 09/14/2026
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown