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

Model Number	M00560070
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	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during hemostasis procedure on (b)(6), 2025.During the procedure, the tip become separated.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: block b1, b2, b5, h1 and h6 (impact codes) have been corrected.Block h6: imdrf device code a0501 captures the reportable event of tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the duodenum during hemostasis procedure on (b)(6) 2025.During the procedure, the tip became separated.The tip was retrieved using tissue clips.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.

• Brand Name: 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: 22955813
• Report Number: 3005099803-2025-04439
• Device Sequence Number: 9591138
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: (01)08714729174691(17)270612(10)36743343
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K970278
• 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): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00560070
• Device Catalogue Number: M00560070
• Device Lot Number: 0036743343
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 06/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown