MAUDE Adverse Event Report: LUMENIS LTD Moses Pulse; Powered Laser Surgical Instrument

Model Number	GA-0006802
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cystolitholapaxy procedure, the console displayed error codes 204 - charger error-charger general failure and 256 - lasing and safety-capacitors voltage fail before pulse delivered.The procedure was stopped and rescheduled.The case was completed with original device, after it was fixed the next day, without patient complications.The patient was under general anesthesia when the case was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
Event or Problem Description
It was reported that during a cystolitholapaxy procedure, the console displayed error codes 204 - charger error-charger general failure and 256 - lasing and safety-capacitors voltage fail before pulse delivered.The procedure was stopped and rescheduled.The case was completed with original device, after it was fixed the next day, without patient complications.The patient was under general anesthesia when the case was cancelled.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.The console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and it was found that the charger in the system was damaged.After the charger was replaced, the problem was resolved, thus, confirming the reported event, that led to the procedure been cancelled.Device was installed on (b)(6) 2021 and this event occurred 4 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A risk review was completed and confirmed that the event of surgical procedure delayed and cancelled/rescheduled - post sedation/sedation unknown is defined in the risk documentation.Therefore, 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; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24441797
• Report Number: 2124215-2026-10350
• Device Sequence Number: 21443471
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)210630(10)183
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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-0006802
• Device Catalogue Number: GA-0006802
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 05/15/2026; 08/21/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/10/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown