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

Model Number	GA-0006801
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy with a laser lithotripsy procedure, multiple fibers were attempted to be used, however, the console repeatedly displayed the error code 48: "fiber other than lumenis sis detected.Please replace fiber." on all four fibers.The procedure was not completed and had to be cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
This console was serviced at the customer's site.The field service engineer (fse) performed the replacement of the lens cell assembly to correct the issue.Upon arrival, the fse verified that the reported error 48 had occurred, therefore the reported event was confirmed.Replacing the lens cell resolved the issue.The console system passed output power and system checklist performance standards.Upon receipt at our quality assurance laboratory, the returned lens cell assembly was visually inspected.It was identified that the lens was clear and clean, however, the electrical cables had been cut or damaged.After the fse performed the replacement of the lens cell, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.Therefore, the investigation was assigned the most probable conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that, during ureteroscopy w laser lithotripsy, multiple moses fibers (two moses 365um and one moses 550um) and a lumenis sis ez 365 fiber were attempted to be used, however, the console repeatedly displayed same error code 48: "fiber other than lumenis sis detected.Please replace fiber." for all four fibers.The procedure was not completed and had to be canceled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that, during ureteroscopy w laser lithotripsy, multiple moses fibers (two moses 365um and one moses 550um) and a lumenis sis ez 365 fiber were attempted to be used, however, the console repeatedly displayed same error code 48: "fiber other than lumenis sis detected.Please replace fiber." for all four fibers.The procedure was not completed and had to be canceled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
This console was serviced at the customer site.The field service engineer (fse) performed the replacement of the lens cell assembly to correct the issue.Upon arrival, the fse verified that the reported error 48 had occurred, therefore the reported event was confirmed.Replacing the lens cell resolved the issue.The console system passed output power and system checklist performance standards.Upon receipt at our quality assurance laboratory, the returned lens cell assembly was visually inspected.It was identified that the lens was clear and clean, however, the electrical cables had been cut or damaged.After the fse performed the replacement of the lens cell, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.Device was installed on (b)(6) 2018 and this event occurred 6 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 cancelled/rescheduled and surgical procedure delayed are defined in the risk documentation.The investigation was assigned the most probable conclusion code of cause traced to component failure.

• 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; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21800513
• Report Number: 2124215-2025-21175
• Device Sequence Number: 8230864
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: (01)07290109145426(11)180605(10)93
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/06/2026

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-0006801
• Device Catalogue Number: GA-0006801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 03/17/2026
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 07/08/2025; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown