MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOXY; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-2400
Medical Device Problem Codes	Nonstandard Device (1420); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the fiber sopped working.The procedure was completed with another of the same device with no patient complications.The fiber returned and it was analyzed identifying the glass tip was detached from the distal end of the fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this fiber was thoroughly analyzed.The visual and microscopic analysis identified the fiber glass tip and metal cap were detached from the distal end of the fiber and not returned.Also, the red indicator was partially worn off the fiber.The fiber was functionally tested using a helium neon (hene) laser fixture, and no signs of breakage along the fiber length were detected.Functional testing demonstrated that the firing output rate was below the threshold for potential patient harm.It is probable that the debris adhesion identified on the surface of the metal cap contributed to elevated temperatures near the laser beam output window.Continuously elevated temperature can lead to fiber damages.The instructions for use (ifu) instructs the user to do not bury the tip in tissue.Do not retract or probe tissue with the device and do not bend at sharp angles.The device history record review confirmed that the device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of fiber stopped working 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.Based on analysis result, the interaction between the user and device caused or contributed to the observed fiber damage and the reported allegation was confirmed.Based on a thorough review of the reported information and investigation results, an investigation conclusion code of unintended use error caused or contributed to the event was assigned to this investigation.

• Brand Name: MOXY
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25622775
• Report Number: 2124215-2026-33853
• Device Sequence Number: 21381007
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: (01)00878953005515(17)270227(10)35949605
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120870
• 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): 06/25/2026

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: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0035949605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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