MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Moxy; Powered Laser Surgical Instrument

Model Number	0010-2400
Medical Device Problem Codes	Break (1069); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a photoselective vaporization of the prostate procedure to treat benign prostatic hyperplasia, the fiber glass cap tip broke and the fiber forward fired while treating the median lobe in the prostate.No fiber fragments fell inside the patient's body.The procedure was completed with a fiber replacement.The patient's outcome was stable.There were no patient complications nor injuries to the operator of the fiber.

• 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; pmt741, persiaran cassia s. 1; taman perindustrial batu kawan; bandar cassia, pulau pinang 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50515526
• Report Number: 2124215-2026-46455
• Device Sequence Number: 21176126
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: (01)00878953005515(17)280213(10)38591491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0038591491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 02/13/2026
• 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