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

Model Number	GA-0008700
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 142 (external indicator - foot switch sw1 status fail), 143 (external indicator - foot switch sw2 status fail) and 58 (self test process failure) were displayed.The patient came for intravesical lithotripsy and holmium laser prostate enucleation.Due to the pedal problem, the physician performed the intravesical lithotripsy with another laser, but did not perform the prostatic enucleation.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Event or Problem Description
It was reported that error 142 (external indicator - foot switch sw1 status fail), 143 (external indicator - foot switch sw2 status fail) and 58 (self test process failure) were displayed.The patient came for intravesical lithotripsy and holmium laser prostate enucleation.Due to the pedal problem, the physician performed the intravesical lithotripsy with another laser, but did not perform the prostatic enucleation.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
B1.Adverse event/product problem: correction d4 unique identifier (udi): correction the console was not returned for analysis.A foot switch was shipped, which resolved the issue.It is likely that the malfunctioning foot switch found could have affected the device performance leading to the event experienced by the customer.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma 6,; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): FLEXTRONICS ISRAEL LTD; hamatechet st 2; migdal haemek 23069 95; IS 2306995
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21606400
• Report Number: 2124215-2025-15697
• Device Sequence Number: 9275369
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)230614(10)1077(21)1077
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/21/2025

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-0008700
• Device Catalogue Number: GA-0008700
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown