MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 550 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-10
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a procedure, a moses laser fiber burned through its own fiber while in use, resulting in a burn injury to the physician which required no treatment.The procedure was completed using a different fiber.The physician is expected to make a full recovery, and there were no reported patient complications.
Additional Manufacturer Narrative
H6 device codes: corrected.
Event or Problem Description
It was reported that, during a procedure, a moses laser fiber burned through its own fiber while in use, resulting in a burn injury in the physician thumb which required no treatment.The procedure was completed using a different fiber.The physician is expected to make a full recovery, and there were no reported patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection found that the fiber body was broken into two pieces, confirming the reported allegation.Microscopic examination of the tip and connector showed no visible abnormalities, as both components appeared to be in good condition.The fiber passed the functional testing performed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the moses fibers hazard analysis was completed and confirmed that the event of fiber break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.According to the device instructions for use (ifu), the following is cautioned: 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.The reported adverse effect of a burn is a known risk associated with use of the device as indicated in the ifu.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that, during a procedure, a moses laser fiber burned through its own fiber while in use, resulting in a burn injury in the physician thumb which required no treatment.The procedure was completed using a different fiber.The physician is expected to make a full recovery, and there were no reported patient complications.

• Brand Name: LUMENIS MOSES 550 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: 24401750
• Report Number: 2124215-2026-09547
• Device Sequence Number: 15521237
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)271106(10)12402504
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0012402504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/19/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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