MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584170
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used during a procedure performed on (b)(6) 2026.During the procedure, when pulling the handle, there is a phenomenon where the wire tip part was bent much more than the normal range.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results: wire broken.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the investigation results of cutting wire break.Block h11: investigation results.The returned truetome 44 was analyzed, and a visual inspection found no visual damages.Functional test was performed; the device was actuated and was unable to bow.Additionally, the device was dissembled, and it was observed that the cutting wire was broken at 25.3 cm from the distal pierce hole.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of wire out of plane bowing was not confirmed.According to the product analysis, it was found that the cutting wire the cutting wire was broken at 25.3 cm from the distal pierce hole.On the other hand, wire out of plane bowing was reported, however, during analysis it was unable to perform the functional test due the device condition (wire broken), therefore, it remains unknown the most probable causes that contributed to the event.Therefore, the most probable root cause is unable to exclude device problem.

• Brand Name: TRUETOME 44
• 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: 24382279
• Report Number: 3005099803-2026-00639
• Device Sequence Number: 10518114
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634(17)270408(10)36258731
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K122203
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: M00584170
• Device Catalogue Number: M00584170
• Device Lot Number: 0036258731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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