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

Model Number	1912-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.Date of event the exact date of the event is unknown, estimated.
Event or Problem Description
It was reported that during an ureteroscopy, the physician was injured in his hands by the fiber.The burn was located on the hand near the wrist and was considered mild severe.The procedure was completed with another fiber without patient complications.Also, an additional intervention was requested.
Event or Problem Description
It was reported that during an ureteroscopy, the physician was injured in his hands by the fiber.The burn was located on the hand near the wrist and was considered mild severe.The procedure was completed with another fiber without patient complications.Also, an additional intervention was requested.
Additional Manufacturer Narrative
B3.Date of event updated.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed and the reported allegation in this complaint has not been confirmed.Visual analysis of the returned fiber showed that the fiber was in good condition, additionally.The fiber was functionally tested with the hene (helium-neon) laser fixture, no signs of breakage along the length of the fiber.Microscope inspection identified no visual or functional failures.During functional testing, the aim beam was bright and round.The device history record confirmed that the device met with all manufacturing specifications prior to distribution and there were no manufacturing deviations.According to the device instructions for use (ifu): 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 and a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.Based on the information available the cause that contributed to the reported event cannot be established.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that during an ureteroscopy, the physician was injured in his hands by the fiber.The burn was located on the hand near the wrist and was considered mild severe.The procedure was completed with another fiber without patient complications.Also, an additional intervention was requested.

• 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: 23696728
• Report Number: 2124215-2025-82028
• Device Sequence Number: 16046237
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)271230(10)11742504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0011742504
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/30/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/23/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown