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

Model Number	GA-0006800
Medical Device Problem Codes	Defective Device (2588); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stone laser procedure, the console shut off and no error codes were reported.The console was rebooted a couple times, the screen froze up and the console did not work.There were no patient complications, however, the case could not be completed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported that during a stone laser procedure, the console shut off and no error codes were reported.The console was rebooted a couple times, the screen froze up and the console did not work.There were no patient complications, however, the case could not be completed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and was found that the key switch and screen assembly, were found damaged.The fse replaced the key switch and screen assembly, as result the console was working as intended, thus confirming the reported event.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
Correction to field h11.Additional mfr narrative.As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console and was found that the key switch and screen assembly, were found damaged.The fse replaced the key switch and screen assembly, as result the console was working as intended, thus confirming the reported event.The key switch was returned and during visual inspections was found that the locking ring was broken; also, the folding display screen was returned, and the visual analysis did not find any anomalies.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 stone laser procedure, the console shut off and no error codes were reported.The console was rebooted a couple times, the screen froze up and the console did not work.There were no patient complications, however, the case could not be completed.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

• 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 6; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21774865
• Report Number: 2124215-2025-20178
• Device Sequence Number: 20883027
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: (01)07290109140513(11)161121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 08/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/09/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown