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	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure to treat bladder stones, the fiber broke in the middle after approximately 10 minutes of use.The procedure was completed with another fiber.There were no patient complications.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, no visual or functional testing was able to be completed.With all the available information, boston scientific concludes that the reported fiber break complaint was not confirmed.The ifu states: if excessive tissue or debris is allowed to accumulate on the laser fiber cap, overheating of the laser fiber cap will occur leading to premature laser fiber degradation and/or laser fiber failure.Do not bend at sharp angles.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 the information available, a conclusion code cause not established was assigned to this investigation.Correction to field h6: impact codes.
Event or Problem Description
It was reported that during a surgical procedure to treat bladder stones, the fiber broke in the middle after approximately 10 minutes of use.The procedure was completed with another fiber.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: 23319131
• Report Number: 2124215-2025-72718
• Device Sequence Number: 5135380
• Product Code: GEX
• UDI-Device Identifier: 07290109143408
• UDI-Public: (01)07290109143408(17)270723(10)14612411
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: 0014612411
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 04/15/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/23/2026; 05/12/2026
• Date Device Manufactured: 01/21/2025
• 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