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

Model Number	M00560160
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The probe did not burn.New probe was from a different lot was opened.The product performed as intended and no further intervention was needed.

• 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
• MDR Report Key: 13901017
• Report Number: 13901017
• Device Sequence Number: 4596289
• Product Code: KNS
• UDI-Device Identifier: 08714729056508
• UDI-Public: (01)08714729056508
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/15/2022
• Report Date (Section F): 03/15/2022

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: M00560160
• Device Lot Number: 27529931
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 95 KG
• Date Report Sent to FDA: 03/15/2022