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

Model Number	M00560070
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific= gold probe used for cautery was deployed in a patient's airway during bronchoscopy procedure to control bleeding.When probe was removed from the bronchoscope we became aware the tip was missing from the instrument.Physician immediately went back to the area where it was used last.Visualized the broken tip and retrieved it intact with suction through the scope thus removing it from the patient's airway with no harm or lasting effects to the patient.

• 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
• MDR Report Key: 19999660
• Report Number: 19999660
• Device Sequence Number: 11981158
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: (01)08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/22/2024
• Report Date (Section F): 07/22/2024

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: M00560070
• Device Lot Number: 33340151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 07/22/2024