MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN STANDARD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36721
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - aware date of (b)(6) 2021 used as date of event not provided.
Event or Problem Description
It was reported foreign material was present on the device.A radiofrequency ablation procedure was being performed.A 4.0cm leveen standard electrode was opened on the sterile field and as the surgeon was about to use it he noticed that at the tip of the needle there was a white substance/debris.It was not used on a patient and handed off the field.The patient was fine and the case was completed.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11411263
• Report Number: 2134265-2021-02760
• Device Sequence Number: 19846914
• Product Code: GEI
• UDI-Device Identifier: 08714729120735
• UDI-Public: 08714729120735
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2021

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: 04/09/2022
• Device Model Number: 36721
• Device Catalogue Number: 36721
• Device Lot Number: 0023624169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/04/2021
• Patient Sequence Number: 1