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

Model Number	1912-10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure outside the patient, the fiber's laser beam showed irradiation failure.The procedure was completed using another fiber without patient complications.Analysis of the returned fiber identified a connector fracture.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was functionally tested.The testing conducted identified that the aim beam light was dim.Visual analysis did not identify any defects to the fiber body.Microscopic analysis identified distorted light exiting the connector face, indicating a possible internal fracture, along with burn marks on the connector face.The tip appeared fine.Fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, it is likely that the interaction between the fractured connector and blast shield led to the burn marks observed on the fiber face.A review of the device instructions for use (ifu) was completed, the ifu states: 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 hold the fiber tip to a non-reflective surface and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber (see fiber tip renewal during operation for details).If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.A risk review was completed and confirmed that the event of no aiming beam 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.A device history record (dhr) review indicated the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure which indicates expected or random component failure without any design or manufacturing issue.

• 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: 25349966
• Report Number: 2124215-2026-29155
• Device Sequence Number: 10326960
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)280123(10)13842507
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/01/2026

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: 0013842507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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