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

Model Number	GA-2003477
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during lithotripsy procedure, the console displayed errors 188: "cooling flow switch error" and 55: "communication protocol error".The laser could not be used and a ureteral stent was placed.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 is unknown.
Additional Manufacturer Narrative
H.6.Impact codes (3): corrected.H.1.Type of reportable event: corrected.B.1.Adverse event/product problem: corrected.This console was serviced at the customer's site.The field service engineer (fse) confirmed error 188 (cooling flow switch error) and error 58 (self-test process failure), and identified that water was leaking from the water tank, causing the water level to decrease, which is thought to be the cause of the errors.The reported event was confirmed.Replacing the water tank resolved the issue.The console system passed functional checks as well as power output tests at all levels.After the field service engineer performed the replacement of the water tank, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.
Event or Problem Description
It was reported that, during lithotripsy procedure, the console displayed errors 188: "cooling flow switch error" and 55: "communication protocol error".The laser could not be used, and a ureteral stent was placed.The procedure had to be cancelled/rescheduled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• 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 st 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21947308
• Report Number: 2124215-2025-27881
• Device Sequence Number: 9121919
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: (01)07290109145440(11)230921(10)1285
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA-2003477
• Device Catalogue Number: GA-2003477
• Device Lot Number: 0000001285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 09/21/2023
• 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