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); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, shortly after firing the laser, the fiber broke and it was unusable.The procedure was completed after replacing the fiber.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Microscope inspection identified that the fiber tip was in good condition, but the connector exhibited severe burn marks.Visual inspection identified that the fiber body was kinked.Therefore, the reported event was confirmed.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.A damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that during procedure, shortly after firing the laser, the fiber broke and it was unusable.The procedure was completed after replacing the fiber.There were no patient complications reported.

• 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: 22873540
• Report Number: 2124215-2025-58677
• Device Sequence Number: 5803110
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)271021(10)10622502
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 11/24/2025

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: 0010622502
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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