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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used in the duodenum during a procedure on an unknown date.During the procedure, the device opened and set up yet was not delivering power.A different device was used to complete the procedure.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, that tip was cracked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf evaluation result code c070603 captures the investigation analysis of distal tip cracked.Block h11: investigation results the returned acquire needle was received for analysis.A microsope inspection revealed that one of the gold band tips was cracked.The reported event was confirmed.Based on the available information, it was determined that tip was cracked, a multimeter was used to perform a continuity test between the banana plug and the gold bands, after the crack in the tip, the gold band did not show continuity it is most likely that handling and manipulation of the device during its use, such as operational factors, the used technique for the device manipulation or by the interaction between the injection gold probe and the scope or hitting against a hard surface, this condition could affect the overall performance of the device, leading to failure to delivery energy.Therefore, a review and analysis of all available information indicated 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: 21762359
• Report Number: 3005099803-2025-01298
• Device Sequence Number: 8455838
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)260211(10)33404213
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 02/11/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0033404213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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