MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Injection Gold Probe; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00560150
Medical Device Problem Codes	Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)
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 h6 imdrf device code a020602 captures the reportable event of "distal tip gold component missing".
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an unknown procedure performed on an unknown date.During preparation, when the needle was intended to be extended, it was noted that the needle was missing from the device.Another device from the same model was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: Injection Gold Probe
• 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: 25354706
• Report Number: 3005099803-2026-02233
• Device Sequence Number: 13424537
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2026

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: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0037805280
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/02/2026; 06/05/2026; 08/24/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/03/2026; 06/30/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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