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

Model Number	GA-2009996
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the console displayed error code 224 - simmer fail error and it did not clear.There were no patient complications, however, the procedure could not be completed.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 cystoscopy retrograde ureteroscopy with laser lithotripsy procedure to treat renal calculus, the console displayed error code 224 - simmer fail error and it did not clear.There were no patient complications, however, the procedure could not be completed, and the patient was under general anesthesia prior to cancelling the procedure.This event is being reported for an aborted/cancelled procedure with a patient under general 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.However, the console was serviced onsite by a field service engineer (fse).The fse found that the switching module (swm) component was damaged.The switching module (swm) component was returned, and visual inspection did not identify any issues.The swm was replaced, and the issue was resolved, hence, the reported event was confirmed.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a cystoscopy retrograde ureteroscopy with laser lithotripsy procedure to treat renal calculus, the console displayed error code 224 - simmer fail error and it did not clear.There were no patient complications, however, the procedure could not be completed, and the patient was under general anesthesia prior to cancelling the procedure.This event is being reported for an aborted/cancelled procedure with a patient under general 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.However, the console was serviced onsite by a field service engineer (fse).The fse found that the switching module (swm) component and coolant were damaged and needed replacement.The switching module (swm) component was returned and the analysis confirmed that a diode within the switching module was damaged.The swm was replaced, and the issue was resolved, thus confirming the report event.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a cystoscopy retrograde ureteroscopy with laser lithotripsy procedure to treat renal calculus, the console displayed error code 224 - simmer fail error and it did not clear.There were no patient complications, however, the procedure could not be completed, and the patient was under general anesthesia prior to cancelling the procedure.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• 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 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19655982
• Report Number: 2124215-2024-40463
• Device Sequence Number: 12418182
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2025

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-2009996
• Device Catalogue Number: GA-2009996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/21/2024; 02/19/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/10/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown