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

Model Number	M00560071
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	09/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 is being used to capture the reportable event of distal tip detachment of device or device component.Impact code f2301is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was intended to be used for a hemostasis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the gold tip of the gold probe fell off the catheter after electrocoagulation.The distal gold tip fell into the patient.The physician grabbed the gold tip of the probe out with the use of a forceps.The procedure was completed with the original device.The patient condition following the procedure was reported as stable, and no patient complications were reported 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 ; +1(914)571-6918
• MDR Report Key: 50887081
• Report Number: 3005099803-2026-03935
• Device Sequence Number: 10667706
• Product Code: KNS
• UDI-Device Identifier: 08714729071013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: M00560071
• Device Catalogue Number: M00560071
• Device Lot Number: 0039205172
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/28/2026
• 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