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

Model Number	GA-0006801
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was repaired on site by the field service engineer (fse).The fse inspected the console, added coolant, verified cooling system operation, tightened key switch assembly.The fse also removed and replaced one blast shield optic, inspected fiber port and lens cell assembly with no visible damage.The fse verified all optical alignments on all four channels of the console.The console is in alignment.The fse verified output power and safety checks.The console works in accordance with boston scientific specifications.The console is operational and ready to use.Based on the service repair information, it is likely that the debris shield was damaged.Therefore, the reported allegation is confirmed.After the fse replaced the debris shield, the issue was resolved, and the console was within specification, and function as intended.It is probable that the damaged debris shield could have affected the device performance leading to the reported event.Based on the investigation results, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the laser console blew two blast shields.The fiber is now stuck on the laser after the second blast shield was blown.The procedure could not be completed due to this event.There were no patient complications reported.This event is being reported for procedure aborted after patient sedation/sedation unknown.
Additional Manufacturer Narrative
The console was repaired on site by the field service engineer (fse).The fse inspected the console, added coolant, verified cooling system operation, tightened key switch assembly.The fse also removed and replaced one blast shield optic, inspected fiber port and lens cell assembly with no visible damage.The fse verified all optical alignments on all four channels of the console.The console is in alignment.The fse verified output power and safety checks.The console works in accordance with boston scientific specifications.The console is operational and ready to use.Based on the service repair information, it is likely that the debris shield was damaged.Therefore, the reported allegation is confirmed.After the fse replaced the debris shield, the issue was resolved, and the console was within specification, and function as intended.It is probable that the damaged debris shield could have affected the device performance leading to the reported event.Based on the investigation results, an investigation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the laser console blew two blast shields.The fiber is now stuck on the laser after the second blast shield was blown.The patient had been sedated with general anesthesia, however, once the issue started and the laser was no longer functioning the procedure was aborted.This did not result in any bleeding issues, but the stones would not be busted up within the bladder.The console was checked the next day and no issue was found.The patient will be brought back in another day to finish the procedure.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: MOSES 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18356662
• Report Number: 2124215-2023-72028
• Device Sequence Number: 17744458
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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-0006801
• Device Catalogue Number: GA-0006801
• Device Lot Number: 0000000312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown