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

Model Number	GA-2006098
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Exact date of event is unknown, therefore first day of bsc aware month was selected.
Event or Problem Description
It was reported that, the emergency stop assembly is broken/damaged.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
G1: mfr site zip/post code: corrected.B5: describe event or problem: corrected.H6: device codes (2): corrected.The console was serviced onsite by a field service engineer (fse).The fse was unable to identify any damage with the emergency button.Upon investigation of the console, replacement of the key switch was recommended to resolve the issue.Therefore, an investigation conclusion code of cause traced to component failure was assigned to this investigation.The initial report was submitted in error with an incorrect imdrf device code a23 (use of device problem).The imdrf device code has been corrected.The manufacturer has reviewed all the information including investigation results and determined this event does not meet reporting criteria for the device in question.B3: exact date of event is unknown; therefore, first day of bsc aware month was selected.
Event or Problem Description
It was reported that, the emergency stop assembly is broken/damaged and the key switch is damaged.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.

• 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): 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: 21700668
• Report Number: 2124215-2025-18547
• Device Sequence Number: 8663792
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: (01)07290109145990(11)210601(10)439(21)439
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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-2006098
• Device Catalogue Number: GA-2006098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown