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

Model Number	GA-0008700
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to procedure, the device's debris shield and fibers were burning.The procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.
Event or Problem Description
It was reported that prior to procedure, the device's debris shield and fibers were burning.The procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.
Additional Manufacturer Narrative
The console device was not returned to the service center but was serviced on-site at the customers facility by a field service engineer (fse).The fse confirmed the reported issue of the device tab window/blast shield issue.The fse found that the focus lens was burned.The focus lens was replaced, and the optical bench was checked, with all components confirmed to be in good condition.A functional test was then performed, and the system passed successfully.The laser is now available, and the system is fully operational.After the field service engineer performed the fiber port replacement, the issue was resolved, and the unit was within specification.As a result, the console is now functioning as intended.The malfunction identified could have affected the device performance, leading to the event experienced by the customer.A review of device history/service history was performed and completed.The device was installed on 13 july 2023, and this event occurred 2 years after the system installation.After this period, component wear, failure or damage is possible based on product use.A review of the device instructions for use (ifu) was performed.The ifu includes specific instructions regarding activation of the laser, stating: inspect the debris shield optic to verify that it is free of any burn marks, scratches, dust, or fingerprints.If the optic is damaged or dirty, replace it with a new one.There was no indication that the device was not used in accordance with the ifu.Additionally, no issues were identified with the ifu translation, wording, or graphics; therefore, revision is not required.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, as an expected or random component failure was identified without any design or manufacturing issues.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23685762
• Report Number: 2124215-2025-87846
• Device Sequence Number: 21259592
• Product Code: GEX
• UDI-Device Identifier: 07290109145464
• UDI-Public: (01)07290109145464(11)230604(10)1059
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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-0008700
• Device Catalogue Number: GA-0008700
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 06/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown