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

Model Number	M00560070
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	10/09/2025
Type of Reportable Event	Serious Injury
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, the gold probe fell off in the patient.The tip of the device was retrieved using a rat tooth.The procedure was completed with an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Imdrf impact code f2301 captures the reportable event of the tip of the device was retrieved using a rat tooth.
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, the gold probe fell off in the patient.The tip of the device was retrieved using a rat tooth.The procedure was completed with an alternate device.There were no patient complications as a result of this event.Additional information received on 11dec2025: the gold probe fell off in the duodenum during an ercp when trying to retrieve a migrated biliary stent.
Additional Manufacturer Narrative
Block h2: additional information.Block b5 has been updated based on the additional information received on december 11.2025.Block d4, h4: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Imdrf impact code f2301 captures the reportable event of the tip of the device was retrieved using a rat tooth.Block h11: investigation results: the gold probe was not returned to the manufacturer for evaluation, as it was disposed at the user facility.However, a media inspection was performed using photos provided by the customer.The image showed that the distal tip was not present.The reported event of distal tip detachment can be confirmed since it was observed in the photo that the distal tip was not present.Based on the available information, 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.Therefore, a review and analysis of all available information indicate the most probable root cause is cause not established.
Additional Manufacturer Narrative
Block h2: additional information block b5 has been updated based on the additional information received on november 10, 2025.Block d4, h4: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Imdrf impact code f2301 captures the reportable event of the tip of the device was retrieved using a rat tooth.Block h11: investigation results the gold probe was not returned to the manufacturer for evaluation, as it was disposed at the user facility.However, a media inspection was performed using photos provided by the customer.The image showed that the distal tip was not present.The reported event of distal tip detachment can be confirmed since it was observed in the photo that the distal tip was not present.Based on the available information, 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.Therefore, a review and analysis of all available information indicate the most probable root cause is cause not established.
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, the gold probe fell off in the patient.The tip of the device was retrieved using a rat tooth.The procedure was completed with an alternate device.There were no patient complications as a result of this event.Additional information was received on november 10, 2025.The anatomy location was colon.

• 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: 23489638
• Report Number: 3005099803-2025-05521
• Device Sequence Number: 8672430
• Product Code: KNS
• UDI-Device Identifier: 08714729174691
• UDI-Public: (01)08714729174691
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/08/2026

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: M00560070
• Device Catalogue Number: M00560070
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 12/11/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/08/2026
• 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