MAUDE Adverse Event Report: Lumenis Ltd Lumenis Moses 200 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the fiber was found to be unusable.Another lot of the device was used to complete the procedure.There was no patient complication.After that, the fiber was returned for analysis and the microscope inspection found that the fiber connector had distorted light exiting the face, indicating an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection found that the fiber body was in good condition.Microscopic inspection found that the fiber connector had distorted light exiting the face, indicating an internal connector fracture.Additionally, the fiber tip was degraded.The connector showed burn marks on the face.During functional test, there was a weak aim beam exiting the fiber tip.Based on this information, the complaint was confirmed.Fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, it is likely that the interaction between the fractured connector and blast shield led to the burn marks observed on the fiber face.A device history record (dhr) review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.The labeling review found that the product instructions for use (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 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.A risk review was completed and confirmed that the event of fiber damaged/defective is defined in the risk documentation.Based on this analysis, the investigation conclusion code assigned is cause traced to component failure which indicates expected or random component failure without any design or manufacturing issue.

• Brand Name: Lumenis Moses 200 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: 50806120
• Report Number: 2124215-2026-49736
• Device Sequence Number: 10589818
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: (01)07290109143170(17)280409(10)15762509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/17/2026

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: 0015762509
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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