MAUDE Adverse Event Report: LUMENIS LTD Lumenis Moses 550 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned fiber found that found the fiber was broken, burn marks were also observed on the connector face.Microscope inspection of the fiber determined that the fiber tip was degraded, and the connector was burnt.Lastly, functional test found error #67, expired.The connector fractured could lead to an insufficient aiming beam or low laser energy output and up to a complete inability for the fiber to fire.A fracture within the connector could occur due to procedural handling of the fiber during setup or use.Also, the interaction between the console and the fracture connector could lead to an overheating of the fiber, that could cause the fiber separated from the connector.The reported clinical observation of fiber not working was confirmed.The instructions for use (ifu) were reviewed and did not reveal any evidence of device off-label use or failure to follow instructions.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.A risk review was completed and confirmed that the reported event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the analysis performed, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that moses fiber blast during the procedure.Procedure was completed with another of the same device.No patient complications were reported.Analysis of the returned fiber identified a fiber body break.

• Brand Name: Lumenis Moses 550 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: 25563877
• Report Number: 2124215-2026-32907
• Device Sequence Number: 21402671
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 0013732506
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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