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

Model Number 36721

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event - aware date of (b)(6) 2021 used as date of event not provided.

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11411263
• MDR Text Key: 234635263
• Report Number: 2134265-2021-02760
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729120735
• UDI-Public: 08714729120735
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1