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

Model Number	GA-2006378
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a flexible ureteroscopy procedure, while attempting to plug into the laser connection port but it would not connect, there was resistance.The fiber broke while trying to disconnect it.Further fibers were opened and attempted to connect before determining that it was a console issue with the connection port.The procedure was rescheduled.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status.
Event or Problem Description
It was reported that during a flexible ureteroscopy procedure, it was attempted to plug the fiber into the laser connection port, but it would not connect and, there was resistance.The fiber broke while trying to disconnect it.Further fibers were opened and attempted to connect before determining that it was a console issue with the connection port.The procedure was rescheduled.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status.

• 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; 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: 20836397
• Report Number: 2124215-2024-75403
• Device Sequence Number: 18327599
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: 07290109144665
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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-2006378
• Device Catalogue Number: GA-2006378
• Device Lot Number: 0000000014
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 03/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown