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

Model Number	GA-0006900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a procedure to lase a stone, a red flashing was observed which concerned the physician.The field representative noted that this flashing has been seen before; she stated it could be caused by an interaction between the laser and the stone or the camera or interference from laser components.It was reported that, following the procedure, the patient developed an unspecified adverse reaction.It was not known whether the procedure caused or contributed to the patient complication.
Event or Problem Description
It was reported that, during a procedure to lase a kidney stone, a red flashing was observed which concerned the physician.The physician opted to abort the procedure before the entire stone was dissolved.The field representative noted that this flashing has been seen before; she stated it could be caused by an interaction between the laser and the stone or the camera or interference from laser components.It was reported that, following the procedure, the patient developed an unspecified adverse reaction.It was not known whether the procedure caused or contributed to the patient complication.

• 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 6; yokneam ; IS
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16616888
• Report Number: 2124215-2023-14104
• Device Sequence Number: 6254746
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: 07290109145402
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GA-0006900
• Device Catalogue Number: GA-0006900
• Device Lot Number: 0000000309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/26/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown