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

Model Number	M00560071
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the lymph node during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the device broke.It was reported that the device detached; however, it is unknown at this time what specifically detached.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information despite good faith efforts.
Additional Manufacturer Narrative
Device code a0501 captures the reportable event of device detachment.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used in the lymph node during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the device broke.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of device detachment.Investigation results: the returned gold probe was analyzed.The visual evaluation found that the tip of the device was detached and not returned.In addition, the working length was found kinked in the distal section.No other problems were noted.The reported event was confirmed.Product analysis identified that the distal tip was detached, and the working length was returned kinked.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician, could have resulted in the damages encountered in the device the detachment and the kink in the working length.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16292672
• Report Number: 3005099803-2023-00321
• Device Sequence Number: 6406428
• Product Code: KNS
• UDI-Device Identifier: 08714729071013
• UDI-Public: 08714729071013
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 09/27/2024
• Device Model Number: M00560071
• Device Catalogue Number: 6007-05
• Device Lot Number: 0030241192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown