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

Model Number	M00560150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the stomach during a hemostasis - for bleeding ulcer procedure performed on (b)(6) 2025.During the procedure, the tip of the gold probe fell off or came off.The procedure was completed using another injection gold probe.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Additional Manufacturer Narrative
Block h2: additional information.Block b5 has been updated.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the stomach during a hemostasis - for bleeding ulcer procedure performed on (b)(6) 2025.During the procedure, the tip of the gold probe fell off or came off.The procedure was completed using another injection gold probe.There were no reported patient complications as a result of this event.Additional information was received on october 15, 2025: the tip was detached but did not fall into the patient.It looked loose and once noticed they removed the probe from the scope and then when they wiggled it, it then fell off.

• 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: 23323383
• Report Number: 3005099803-2025-05446
• Device Sequence Number: 9909845
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)260612(10)34227169
• 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
• Report Date (Section B): 11/06/2025

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 Expiration Date: 06/12/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0034227169
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 06/12/2024
• 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