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

Model Number	1912-10
Medical Device Problem Codes	Break (1069); Smoking (1585)
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 holmium laser enucleation of the prostate procedure, fiber started smoking where the fiber connects to the laser.The procedure was completed using another fiber of the same lot number.No further information was provided.
Additional Manufacturer Narrative
The device is not available for analysis as the device was disposed by healthcare facility; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Device history record (dhr) review was completed, and it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.The instructions for use (ifu) was reviewed.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.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 break 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 information available the cause that contributed to the reported event cannot be established, therefore, an investigation conclusion code of cause not established was assigned to this investigation.

• 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: 50132672
• Report Number: 2124215-2026-41756
• Device Sequence Number: 13390439
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)280917(10)11512603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 0011512603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 03/19/2026
• 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