MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 365 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an enucleation of the prostate procedure, the fiber working element fractured distally when the physician activated the enucleation pedal.The physician trimmed the fiber tip successfully and proceeded to complete the procedure with the same fiber without patient consequences.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the fiber identified that the fiber body was fragmented into 2 pieces, confirming the reported event.The observed fiber tip was found degraded; this is normal degradation of the fiber which occurred through fiber use.Microscope inspection confirmed that the fiber connector was in good condition.A labeling review was conducted on the instruction for use and the ifu has instructions and warnings against fiber breaking.These ifu state: 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.Hold the fiber tip to a nonreflective surface and ensure that a circular green spot appears.If the spot is not circular, re-cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Based on review of all information available and analysis results, a conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation.
Event or Problem Description
It was reported that during an enucleation of the prostate procedure, the fiber working element fractured distally when the physician activated the enucleation pedal.The physician trimmed the fiber tip successfully and proceeded to complete the procedure with the same fiber without patient consequences.

• Brand Name: LUMENIS MOSES 365 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: 23420645
• Report Number: 2124215-2025-76042
• Device Sequence Number: 9571470
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)270514(10)13912410
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 0013912410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOSES P120 LUMENIS CONSOLE.; MOSES P120 LUMENIS CONSOLE.
• Patient Sex: Male