MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 550 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-10
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at the quality assurance laboratory, the device was visually and functionally evaluated.Visual inspection identified that the fiber body was broken into two pieces.Microscopic inspection showed that the tip was clipped; however, the connector appeared normal with no visible abnormalities.Functional testing passed, and the console reading indicated zero treatments used with one treatment remaining.These findings indicate that the issue was limited to a physical fiber body break, while the connector integrity and console communication remained within normal operating conditions.Based on analysis results and information available, no device malfunction was reported; therefore, complaint confirmation could not be performed.A labeling review verified that the instructions for use (ifu) instruct users to inspect the fiber for any visible damage such as kinks or fractures prior to use and to discontinue use and replace the fiber if damage is observed, as a damaged fiber may result in accidental laser exposure or injury to the user or patient.Fiber break events for this device type are under further investigation; therefore, a conclusion code of cause traced to device but unable to determine more specifically was assigned.
Event or Problem Description
It was reported that the fiber was returned without initial reporter and performance allegation information.Analysis of the returned device identified that the fiber was broken.

• 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): 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: 24348589
• Report Number: 2124215-2026-08584
• Device Sequence Number: 9887823
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)271216(10)13262506
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 0013262506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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