MAUDE Adverse Event Report: Lumenis Ltd Lumenis Moses 365 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, there was a noise and the fiber blew up.The procedure was completed without patient complications by replacing the fiber.Product analysis of the returned device identified a fracture at the fiber cap/tip.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the device identified that the fiber body was in good condition.Microscope analysis showed that the fiber tip was broken as well as the connector had burn marks and light was coming through.The functional test also determined that the aiming beam was dim, and the console presented with error #52 - the fiber has reached the maximum allowed number of uses.After performing all the corresponding tests, the allegation of fiber cap/tip - blew/burned out was confirmed.A fiber tip breakage and burn marks on the connector were also identified.A device history record (dhr) review was performed and no manufacturing deviations related to this device and event were found.A risk review was completed and confirmed that the events of fiber cap/tip - blew/burned out, fiber tip broken and connector burnt are defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.The labeling review found that the product ifu (instructions for use) 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 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.It is likely that the fiber breakage may have been contributed to procedural conditions such as physician technique, size and composition of the material being ablated.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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): LUMENIS LTD; 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: 50848464
• Report Number: 2124215-2026-50319
• Device Sequence Number: 9953418
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)280108(10)11772504
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 0011772504
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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