MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INJECTION GOLD PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00560150
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf impact code f1001 captures the reportable event of aborted/canceled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the stomach during a gastroscopy procedure on (b)(6) 2025.During the procedure, the injection gold probe could not be energized.As a result, hemostasis was attempted using clips; however, endoscopic control of the bleeding was unsuccessful, and the procedure was converted to surgery.The patient subsequently made a full recovery.
Additional Manufacturer Narrative
Block h2: additional information.Physician email address has been updated.Block h6: imdrf impact code f1001 captures the reportable event of aborted/canceled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the stomach during a gastroscopy procedure on (b)(6) 2025.During the procedure, the injection gold probe could not be energized.As a result, hemostasis was attempted using clips; however, endoscopic control of the bleeding was unsuccessful, and the procedure was converted to surgery.The patient subsequently made a full recovery.
Additional Manufacturer Narrative
Block h2: correction to the b5 block h6: imdrf impact code f1001 captures the reportable event of aborted/canceled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the stomach during a gastroscopy procedure on (b)(6) 2025.During the procedure, the injection gold probe could not be energized.Hemostasis was attempted using clips; however, it was unsuccessful because the source of bleeding could not be visualized.The procedure was therefore converted to surgery; sutures were applied to control the bleeding.The patient subsequently made a full recovery.

• 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 ; 9145716918
• MDR Report Key: 22585783
• Report Number: 3005099803-2025-03250
• Device Sequence Number: 14593789
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)270320(10)36113233
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133933
• 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,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 0036113233
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 02/06/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/28/2025; 02/11/2026
• Date Device Manufactured: 03/20/2025
• 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