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	Burn(s) (1757)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber broke and burned the patient somewhere near abdomen.The case was completed with another fiber.The burn was treated with bacitracin, and it was considered a severe mild burn.
Additional Manufacturer Narrative
Correction to field h1.Type of reportable event.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.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.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such in the instructions for use.
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber broke and burned the patient somewhere near abdomen.The case was completed with another fiber.The burn was treated with bacitracin, and it was considered a severe mild burn.

• 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: 23343077
• Report Number: 2124215-2025-69948
• Device Sequence Number: 13129164
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)270716(10)14552411
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0014552411
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/28/2025
• Date Device Manufactured: 01/14/2025
• 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