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

Model Number	M00560150
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure on (b)(6) 2025.During the procedure, the physician tried to use a gold probe to cauterize a bleeder, but it did not work upon pressing the foot pedal to give the gold probe energy.The procedure was completed using another gold probe.There were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results; the tip was cracked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf result code c070603 captures the investigation analysis of the tip cracked.Block h11: investigation results- the returned injection gold probe was received for analysis, and it was found during microscope inspection that the distal tip was cracked and had friction marks.In addition, the device did show continuity between the banana plug and the gold band before the cracked section but did not show continuity after the cracked section.The reported event was confirmed.Based on the available information, the investigation findings of distal tip cracked were most likely due to operational factors, the technique used for manipulation, or by the interaction between the injection gold probe and the scope (hitting against a hard surface).This condition could affect the overall performance of the device, leading to failure delivering energy.Once the band is cracked the current cannot pass to the rest of the tip.Therefore, a review and analysis of all available information indicates the most probable cause is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21859571
• Report Number: 3005099803-2025-01638
• Device Sequence Number: 15433006
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)260416(10)33837299
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/17/2025

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 Expiration Date: 04/16/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0033837299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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