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

Model Number	M00584240
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sphinctertome inserted through duodenoscope noted by tech that the sphinctertome was in "bow" position already and sphinctertome handle not being able to change bow angle when moved.Sequestered and reported to boston rep.

• Brand Name: JAGTOME¿ REVOLUTION RX
• 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: 21468366
• Report Number: 21468366
• Device Sequence Number: 8822320
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: (01)08714729953234
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/23/2025
• Report Date (Section F): 01/23/2025

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
• Device Model Number: M00584240
• Device Catalogue Number: M00584260
• Device Lot Number: 35116189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Date Report Sent to FDA: 01/23/2025