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

Model Number	6010-05
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, it was evident that the top of the gold probe had detached inside the patient.It was unknown how was the tip of the device retrieved from the patient and the procedure was completed using another gold probe.There were no patient complications reported 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.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, it was evident that the top of the gold probe had detached inside the patient.It was unknown how was the tip of the device retrieved from the patient and the procedure was completed using another gold probe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information.Block a2: age, a3a, a3b and a4 have 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 a gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, it was evident that the top of the gold probe had detached inside the patient.It was unknown how was the tip of the device retrieved from the patient and the procedure was completed using another gold probe.There were no patient complications reported 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 information: e1 initial reporter name updated based on additional information received on 17oct2025.Block h11: investigation results the gold probe was not returned.However, media inspection it was possible to observed that the distal tip is not present, and it had two wires.The reported event was confirmed.Based on the available information, there is not enough evidence to determine whether the issue was induced due to the physician's technique during the procedure or was related to a device malfunction.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.

• 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: 23323392
• Report Number: 3005099803-2025-05447
• Device Sequence Number: 9909849
• Product Code: KNS
• UDI-Device Identifier: 08714729071020
• UDI-Public: (01)08714729071020(17)260530(10)34139860
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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: 05/30/2026
• Device Model Number: 6010-05
• Device Catalogue Number: 6010-05
• Device Lot Number: 0034139860
• 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: 10/17/2025; 10/28/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/11/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 85 KG