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

Model Number	M00573100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire failure to release bow.Block h11: investigation results.The device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of wire failure to release bow could not be confirmed.The device was not returned because it was disposed.The customer provided a picture where it was possible to observe the opened and labeled pouch and the device with what appears to be the wire unable to release bow; however, the handle was not visible to determine whether the device was actuated or in the extended position.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was prepared to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gall stones performed on (b)(6) 2026.During preparation, the physician inspected the tome and noted that the wire was excessively bent.The nurse attempted to open the handle to adjust the tome, but the wire could not be straightened further.The customer provided a picture where it was possible to observe the device was on a semi bowed state.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.

• Brand Name: JAGTOME 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25251476
• Report Number: 3005099803-2026-02024
• Device Sequence Number: 9562692
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: (01)08714729776536(17)290212(10)38598766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013153
• 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): 05/22/2026

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: M00573100
• Device Catalogue Number: M00573100
• Device Lot Number: 0038598766
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• 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