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

Model Number	GA-0006802
Medical Device Problem Codes	Material Integrity Problem (2978); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 initial reporter's address 1: (b)(6).
Event or Problem Description
It was reported that this device burned a fiber during a procedure and was determined that the fiber optic cable had been burned out due to misuse by the user.The procedure was completed with low power instead.There was no report of patient complications.
Event or Problem Description
It was reported that this device burned a fiber during a procedure and was determined that the fiber optic cable had been burned out due to misuse by the user.The procedure was completed with low power instead.There was no report of patient complications.
Additional Manufacturer Narrative
Block e1 initial reporter's address 1: (b)(6).The console was not returned for analysis; however, it was serviced on site by a field service engineer (fse).The reported event of low power was not confirmed.It was confirmed that the power levels improved after stripping and trimming the burned section of the fiber tip.The condition of the blast shield and the internal lenses of each brick were also checked and found to be in good condition.Beam alignment and centering were verified, including near and far alignment tests.The equipment's performance was confirmed using a service fiber that the power levels were within manufacturer's specifications.And the user received a detailed explanation of the proper use of the laser and fibers, along with recommendations to use a microscope for fiber inspection and appropriate tools for stripping and cutting.Based on the information available, the investigation conclusion code assigned was device problem excluded.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 24059946
• Report Number: 2124215-2026-02232
• Device Sequence Number: 9875261
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: (01)07290109145525(11)250129(10)2029
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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-0006802
• Device Catalogue Number: GA-0006802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown