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

Model Number	GA-2009996
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laser lithotripsy procedure, the console was not firing and there were no error codes displayed.It was tried to change the fiber, but the error persisted.The procedure was not completed, only the stent was placed.The patient was under general anesthesia and there were no patient complications reported.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
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 there were no defects noticed.The device was tested with multiple test fibers, and rebooted, but there were no errors.The unit worked as intended, therefore the reported allegation could not be confirmed.The fse ran calibrations and checked output power and all the values were within specifications.Based on the analysis, a conclusion code of no problem detected was assigned to this event, since the device operated properly.
Event or Problem Description
It was reported that during a laser lithotripsy procedure, the console was not firing and there were no error codes displayed.It was tried to change the fiber, but the error persisted.The procedure was not completed, only the stent was placed.The patient was under general anesthesia and there were no patient complications reported.This event is being reported for an 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): 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: 19431135
• Report Number: 2124215-2024-31673
• Device Sequence Number: 12769878
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/16/2024

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-2009996
• Device Catalogue Number: GA-2009996
• Device Lot Number: 000000001097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown