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

Model Number	0010-2400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the fiber tip was damaged as the metal cap detached.It became dislodged inside the body.The dislodged metal cap was removed from the body using forceps.The case was completed with another of same device without patient complications.The physician and the medical engineer reported that there was no movement that could have caused the tip to come off during the procedure.
Additional Manufacturer Narrative
Update to section b5 (describe event or problem).Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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; 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: 50000234
• Report Number: 2124215-2026-39715
• Device Sequence Number: 10624974
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: (01)00878953005515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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: 0038361395
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 07/23/2026; 08/07/2026; 08/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/03/2026; 08/18/2026; 09/14/2026
• Date Device Manufactured: 01/16/2026
• 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