MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUEtome 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00584170
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: the initial reporter address 1 is av presidente affonso camargo 1399; reported here as the initial reporter address 1 exceeded the character limit for the designated field.Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the sterile packaging of the device.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was checked in the stockroom.The exact event date was unknown.During the inventory, a foreign object was found in the packaging.Specifically, a hair was observed within the sterile pouch, visible on the white section of the packaging on the right side.No patient and procedure were involved in this event.Note: photos of the complaint device inside the unopened packaging were provided by the customer and shows a hair-like particle inside the sterile device packaging.

• 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 ; +1(914)571-6918
• MDR Report Key: 25452705
• Report Number: 3005099803-2026-02320
• Device Sequence Number: 16043063
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634(17)271210(10)38154032
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 0038154032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 12/10/2025
• 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