MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 365 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during enucleation, the fiber was fractured distally when the pedal was activated.It was noted that the break occurred in the segment that was entirely within the working element.The fiber was successfully trimmed, and the procedure was completed using the original device.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during enucleation, the fiber was fractured distally when the pedal was activated.It was noted that the break occurred in the segment that was entirely within the working element.The fiber was successfully trimmed, and the procedure was completed using the original device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection revealed that the fiber was received in two pieces and had a fiber body break.Microscopic inspection showed that the fiber tip was degraded, while the connector appeared to be intact.Functional testing was subsequently performed, and the console displayed the following message: error 67, expired.Treatments used: 1; treatments remaining: 0.A review of the device instructions for use (ifu) was completed and states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use it; return it to the supplier for replacement.A damaged fiber may cause accidental laser exposure or injury to treatment room personnel or the patient, and/or fire in the treatment room.Hold the fiber tip to a non-reflective surface and ensure that a circular green spot appears.If the spot is not circular, re-cleave the fiber (see fiber tip renewal during operation for details).If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Based on the available information and analysis results, a conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation.
Event or Problem Description
It was reported that during enucleation, the fiber was fractured distally when the pedal was activated.It was noted that the break occurred in the segment that was entirely within the working element.The fiber was successfully trimmed, and the procedure was completed using the original device.There were no patient complications.

• Brand Name: LUMENIS MOSES 365 D\F\L
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23441624
• Report Number: 2124215-2025-77520
• Device Sequence Number: 11957793
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)271118(10)11362503
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0011362503
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 03/03/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/12/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male