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	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used on a procedure on (b)(6) 2025.During the procedure, the probe was found to be not heating upon contact with the patient's mucosa.When the equipment was withdrawn from the biopsy channel, the tip of the probe was observed to be missing.A photo of the probe was provided, showing that the distal gold tip was no longer attached to the end of the catheter.Another same device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6: imdrf device code a0501 captures the reportable event of distal tip detachment of device or device component.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment of device or device component.Block h11: the injection gold probe was not returned for analysis.However, a photo of the device was provided, and media inspection observed the distal tip was detached.Based on all available information, the most probable root cause cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Since 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, the most probable root cause cannot be established.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used on a procedure on (b)(6) 2025.During the procedure, the probe was found to be not heating upon contact with the patient's mucosa.When the equipment was withdrawn from the biopsy channel, the tip of the probe was observed to be missing.A photo of the probe was provided, showing that the distal gold tip was no longer attached to the end of the catheter.Another same device was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 23248728
• Report Number: 3005099803-2025-05143
• Device Sequence Number: 10441668
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)270602(10)36658800
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0036658800
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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