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); Nonstandard Device (1420); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate (holep) procedure to treat an enlarged prostate, 3 fibers exhibited an audible clicking noise originating from the working end of the fiber tip when the console's pedal was being pressed.2 joules and 50 hertz had been used during procedure, and the energy was not being emitted properly.The sheath that surrounded the fibers was coming apart.The working tips of the fibers were asymmetrical and broken.However, no fiber fragments were seen inside the patient.All 3 fibers and the console were replaced, and the procedure was completed.There were no injuries to the operator or patient; there were no patient complications.Fiber 1 of 3.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate (holep) procedure to treat an enlarged prostate, 3 fibers exhibited an audible clicking noise originating from the working end of the fiber tip when the console's pedal was being pressed.2 joules and 50 hertz had been used during procedure, and the energy was not being emitted properly.The sheath that surrounded the fibers was coming apart.The working tips of the fibers were asymmetrical and broken.However, no fiber fragments were seen inside the patient.All 3 fibers and the console were replaced, and the procedure was completed.There were no injuries to the operator or patient; there were no patient complications.Fiber 1 of 3.
Additional Manufacturer Narrative
The fiber was not available for analysis; therefore, no physical analysis of the product could be performed.The allegations of "fiber break", "fiber peeled", and "fiber operates differently than expected" cannot be confirmed.A media review was completed and did not provide clear evidence or showed a fiber tip/cap break nor peeling on the fiber.A labeling review was completed, and the instructions for use (ifu) states, "warning - a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room." and "inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appeared damaged, do not use the fiber; return it to the supplier for replacement." a risk review was completed and confirmed that the reported issues were defined in the risk documentation.The device history record (dhr) was reviewed and did not identify evidence of deviations or non-conformances in the manufacturing process that could have contributed to the complaint.The dhr review confirms that the accepted was manufactured per the device master record.Based on the information provided, the most probable cause of the reported issues cannot be established due to lack of evidence.Since the investigation findings do not lead to a clear conclusion about the cause of the reported events, the investigation conclusion code selected was cause not established for this complaint.

• 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: 24534734
• Report Number: 2124215-2026-11544
• Device Sequence Number: 16036700
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)280427(10)16432510
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 0016432510
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 10/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MOSES FIBER 2 UPN: AC-10030120 & LOT: 16432510; MOSES FIBER 2 UPN: AC-10030120 & LOT: 16432510; MOSES FIBER 3 UPN: AC-10030120 & LOT: 16432510; MOSES FIBER 3 UPN: AC-10030120 & LOT: 16432510; P120 CONSOLE UPN: GA-0006802 & SN: (B)(6); P120 CONSOLE UPN: GA-0006802 & SN: (B)(6)
• Patient Sex: Male