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	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior the procedure for urethral stones, it was noticed the fiber was cracked upon screwing in the fiber, it was visible when it was plugged into the console.Due to this, the procedure was completed using another device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified the fiber body was broken and was being held together by the fiber jacket.The microscopic analysis found the fiber tip and connector are in good condition.According to the ifu, the user is instructed to 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; if 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 reported fiber break allegation was identified; however, the most probable cause of fiber break could not be determined, therefore an investigation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that prior the procedure for urethral stones, it was noticed the fiber was cracked upon screwing in the fiber, it was visible when it was plugged into the console.Due to this, the procedure was completed using another device.There were no patient complications.

• 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): LUMENIS LTD.; yokneam industrial park; hakidma street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23327686
• Report Number: 2124215-2025-73605
• Device Sequence Number: 16105167
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)271217(10)11612503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 0011612503
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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