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

Model Number	1912-10
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber had a defect and stopped working during the procedure.The procedure was completed using another fiber of the same model.There were no patient complications.The device was analyzed in the laboratory, and it was identified that the fiber body was broken in addition to the fiber tip.
Additional Manufacturer Narrative
Upon receipt this fiber at our quality assurance laboratory, the device was thoroughly analyzed.Visual inspection revealed that the fiber was received in two separate pieces, indicating a break in the fiber body.Microscopic examination confirmed that the fiber tip was broken, while the connector showed no structural defects, aside from mild burn marks.Functional testing of the fiber on the console displayed the message: error #67 fiber expired.Treatments used: 1.Treatments left: 0.The observed condition of a broken fiber body and tip is consistent with a fiber break event.Such damage may occur during procedural handling, including setup, use, or reprocessing.The labeling review found that the product 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.And: ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.

• 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: 22911415
• Report Number: 2124215-2025-60047
• Device Sequence Number: 18424594
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)270530(10)14022410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0014022410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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