MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME¿ RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During sphincterotomy dr was using the tome39 and vizi wire.Upon bowing the tome and activating the foot pedal, the distal end of the tome became detached exposing the wire.Immediately removed and replaced with second tome (same lot) and the same issue occurred again.This report is for device #2.

• Brand Name: AUTOTOME¿ RX 39
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23037063
• Report Number: 23037063
• Device Sequence Number: 18505330
• Product Code: KNS
• UDI-Device Identifier: 08714729444770
• UDI-Public: (01)08714729444770
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/28/2025
• Report Date (Section F): 08/28/2025

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: M00545200
• Device Lot Number: 36127358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 08/28/2025