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

Model Number	1912-10
Medical Device Problem Codes	Break (1069); Gas Output Problem (1266); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the green plastic was coming off the tip.Less energy was noticed.There was fiber tip degradation and fraying.The procedure was completed using another fiber.There were no patient complications.
Event or Problem Description
It was reported that during procedure the green plastic (ptfe jacket) on the fiber tip was coming off.Less energy was noticed.There was fiber tip degradation and fraying.The procedure was completed using another fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Visual inspection did not find visible defects on the fiber body.Functional testing identified that the aim beam light was distorted.Upon microscope inspection it was identified that the connector was in good condition, however, the fiber tip was broken.Therefore, the reported event was confirmed.Device history record (dhr) review confirmed that the device met all material, assembly and performance specifications, and therefore the failure was unlikely related to manufacturing.The device instructions for use (ifu) was reviewed.The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.Hold the fiber tip to a non-reflective surface, and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.
Event or Problem Description
It was reported that during procedure the green plastic (ptfe jacket) on the fiber tip was coming off.Less energy was noticed.There was fiber tip degradation and fraying.The procedure was completed using another fiber.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: 23408353
• Report Number: 2124215-2025-77136
• Device Sequence Number: 9018873
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)280131(10)12382504
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0012382504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 12/15/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/20/2025; 01/06/2026
• Date Device Manufactured: 08/01/2025
• 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: Unknown