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

Model Number	GA-0006902
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not recognize the fiber due to debris on the fiber port threads.The procedure was not completed due to this event.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.
Additional Manufacturer Narrative
The device was not returned for product analysis; therefore, no physical analysis of the device could be performed.However, the field service engineer (fse) serviced the device at the customer facility.It was found that the device did not recognize the fiber due to debris on the lens cell thread, possibly from manufacturing.The last 1.5 turns of the fiber were becoming tight and rigid.The internal port was inspected, and no debris was observed.The fiber port threads were cleaned, after which the device was retested, and the issue was found to be resolved.The device subsequently passed functional testing and was verified to be operating as intended and suitable for clinical use.Media inspection was also performed and found that the fiber port is dirty.The malfunction found could have affected the device performance leading to the event experienced by the customer.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review was completed and confirmed that the events of cancelled/rescheduled - post sedation/sedation unknown and surgical procedure delayed were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that expected or random component failures were identified, with no design or manufacturing issues found.

• 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 st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25841740
• Report Number: 2124215-2026-38256
• Device Sequence Number: 10582392
• Product Code: GEX
• UDI-Device Identifier: 07290109145150
• UDI-Public: (01)07290109145150(11)250902(10)2302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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-0006902
• Device Catalogue Number: GA-0006902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown